CARPUJECT HOLDER
Report
- Report Number
- 1810189-2024-00037
- Event Type
- Malfunction
- Date Received
- October 10, 2024
- Report Date
- September 28, 2024
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- IQG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
EVENT [PREFERRED TERM] DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [DEVICE DIFFICULT TO USE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM. THE REPORTER REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (PRIVACY) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND MYSELF, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY IN-SERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS-ON IN-SERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT.: CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 18NOV2024 FOR CARPUJECT HOLDER: THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. DEVICE ENGINEERING CONCLUSION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, IFU - UNCLEAR WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (INX100388227, VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (08NOV2024): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (18NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS.
EVENT VERBATIM [PREFERRED TERM] DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [NO ADVERSE EVENT],, NARRATIVE: THIS CASE HAS BEEN CONSIDERED INVALID AS NO AE. THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM. THE REPORTER REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (PRIVACY) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND I, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY IN-SERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS-ON IN-SERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT.: CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 18NOV2024 FOR CARPUJECT HOLDER: THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. DEVICE ENGINEERING CONCLUSION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, IFU - UNCLEAR WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (INX100388227, VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (08NOV2024): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (18NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM MALFUNCTION TO NOT DEVICE RELATED. THIS CASE HAS BEEN CONSIDERED INVALID AS NO AE. INVESTIGATION SUMMARY COMPLETE DATE(GMT): 18NOV2024. MDCP INVESTIGATION SUMMARY AND CONCLUSION: THIS COMPLAINT OF WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY INSERVICE MATERIALS AVAILABLE? FOR CARPUJECT HOLDER WAS INVESTIGATED BY THE MANUFACTURING SITE. THE PURPOSE OF THIS INVESTIGATION IS TO INVESTIGATE A REPORT RECEIVED ASSOCIATED WITH AN UNKNOWN LOT OF CARPUJECT HOLDER. CALLER STATES THAT THEIR HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. AS THERE IS NO DEFECT OR FAILURE BEING REPORTED, A ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WILL NOT BE PERFORMED SINCE THE END USER IS ONLY INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM. INFORMATION REGARDING HOW TO USE THE CARPUJECT AND CARPUJECT HOLDERS CAN BE FOUND IN VARIOUS LOCATIONS: INSTRUCTIONS FOR USE OF CARPUJECTS WITH HOLDER ARE AVAILABLE AT PFIZERPRO.COM. A CARPUJECT TRAINING POSTER, BROCHURES, AND PRODUCT DEMONSTRATION VIDEO CAN BE FOUND AT "READYTOUSE.PFIZERPRO.COM." THE READY-TO-USE (RTU) DELIVERY SYSTEM LEARNING WEBSITE, "LEARNPFIZERRTU.COM," PROVIDES: OVERVIEW OF PFIZER HOSPITAL READY-TO-USE PRODUCTS (INCLUDING THE CARPUJECTS AND HOLDERS). VIDEOS DEMONSTRATING USE INTERACTIVE KNOWLEDGE CHECKS TO REINFORCE LEARNINGS. LINKS TO TOOLS AND RESOURCES NO COMPLAINT SAMPLES NOR PICTURES WERE RECEIVED OR REQUESTED TO ASSIST IN THE INVESTIGATION AS A MANUFACTURE DEFECT IS NOT BEING REPORTED. THE BATCH RECORD, LOT TRENDING, LOT INVESTIGATION QUERY, MANUFACTURE PROCESS TREND QUERY, AND APRR WERE NOT PERFORMED AS THERE IS NOT A MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT AND A LOT NUMBER WAS NOT PROVIDED. COMPLAINT SUB-CLASS TRENDING WAS PERFORMED FOR NON-DEFECT - LABELING UNCLEAR/CONFUSING/REQUIRES IMPROVEMENT FOR THE CARPUJECT/CARPUJECT HOLDER PRODUCT WITH 16 INVESTIGATIONS BEING RETURNED FOR THE TWO-YEAR QUERY TIME FRAME. PER THE DEFINED CRITERIA NO TREND WAS IDENTIFIED THEREFORE, THIS EVENT WILL NOT BE ELEVATED TO COMPLAINT MANAGEMENT REVIEW BOARD (CMRB). THE FINAL SCOPE WILL BE LIMITED TO AN UNKNOWN LOT NUMBER OF CARPUJECT HOLDER AS THERE IS NOT A REPORTED MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT, INSTEAD THE END USER WAS INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM SAFELY AND EFFECTIVELY. NO FURTHER INVESTIGATION IS REQUIRED. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THIS COMPLAINT WAS ALSO INVESTIGATED BY DEVICE ENGINEERING. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (INX100388227, VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. THIS CASE IS BEING DELETED FROM THE DATABASE FOR THE FOLLOWING REASON: EXISTENCE OF ADVERSE EVENT NOT CONFIRMED AT FOLLOW-UP.
EVENT VERBATIM [PREFERRED TERM] DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [DEVICE DIFFICULT TO USE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM. THE REPORTER REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (PRIVACY) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND MYSELF, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY IN-SERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS ON IN-SERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT. CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY COMPLETE DATE(GMT): 18NOV2024. MDCP INVESTIGATION SUMMARY AND CONCLUSION: THIS COMPLAINT OF WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY INSERVICE MATERIALS AVAILABLE? FOR CARPUJECT HOLDER WAS INVESTIGATED BY THE MANUFACTURING SITE. THE PURPOSE OF THIS INVESTIGATION IS TO INVESTIGATE A REPORT RECEIVED ASSOCIATED WITH AN UNKNOWN LOT OF CARPUJECT HOLDER. CALLER STATES THAT THEIR HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. AS THERE IS NO DEFECT OR FAILURE BEING REPORTED, A ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WILL NOT BE PERFORMED SINCE THE END USER IS ONLY INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM. INFORMATION REGARDING HOW TO USE THE CARPUJECT AND CARPUJECT HOLDERS CAN BE FOUND IN VARIOUS LOCATIONS: INSTRUCTIONS FOR USE OF CARPUJECTS WITH HOLDER ARE AVAILABLE AT PFIZERPRO.COM. A CARPUJECT TRAINING POSTER, BROCHURES, AND PRODUCT DEMONSTRATION VIDEO CAN BE FOUND AT "READYTOUSE.PFIZERPRO.COM." THE READY-TO-USE (RTU) DELIVERY SYSTEM LEARNING WEBSITE, "LEARNPFIZERRTU.COM," PROVIDES: OVERVIEW OF PFIZER HOSPITAL READY-TO-USE PRODUCTS (INCLUDING THE CARPUJECTS AND HOLDERS). VIDEOS DEMONSTRATING USE INTERACTIVE KNOWLEDGE CHECKS TO REINFORCE LEARNINGS. LINKS TO TOOLS AND RESOURCES NO COMPLAINT SAMPLES NOR PICTURES WERE RECEIVED OR REQUESTED TO ASSIST IN THE INVESTIGATION AS A MANUFACTURE DEFECT IS NOT BEING REPORTED. THE BATCH RECORD, LOT TRENDING, LOT INVESTIGATION QUERY, MANUFACTURE PROCESS TREND QUERY, AND APRR WERE NOT PERFORMED AS THERE IS NOT A MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT AND A LOT NUMBER WAS NOT PROVIDED. COMPLAINT SUB-CLASS TRENDING WAS PERFORMED FOR NON-DEFECT - LABELING UNCLEAR/CONFUSING/REQUIRES IMPROVEMENT FOR THE CARPUJECT/CARPUJECT HOLDER PRODUCT WITH 16 INVESTIGATIONS BEING RETURNED FOR THE TWO-YEAR QUERY TIME FRAME. PER THE DEFINED CRITERIA NO TREND WAS IDENTIFIED THEREFORE, THIS EVENT WILL NOT BE ELEVATED TO COMPLAINT MANAGEMENT REVIEW BOARD (CMRB). THE FINAL SCOPE WILL BE LIMITED TO AN UNKNOWN LOT NUMBER OF CARPUJECT HOLDER AS THERE IS NOT A REPORTED MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT, INSTEAD THE END USER WAS INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM SAFELY AND EFFECTIVELY. NO FURTHER INVESTIGATION IS REQUIRED. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THIS COMPLAINT WAS ALSO INVESTIGATED BY DEVICE ENGINEERING. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (B)(4) VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (B)(6) 2024): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (18NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM MALFUNCTION TO NOT DEVICE RELATED. THIS CASE HAS BEEN CONSIDERED INVALID AS NO AE. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM NOT DEVICE RELATED, TO VALID FOR MALFUNCTION.
DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [DEVICE DIFFICULT TO USE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM. THE REPORTER REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (PRIVACY) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND MYSELF, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY IN-SERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS ON IN-SERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT. CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY COMPLETE DATE(GMT): 18NOV2024. MDCP INVESTIGATION SUMMARY AND CONCLUSION: THIS COMPLAINT OF WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY INSERVICE MATERIALS AVAILABLE? FOR CARPUJECT HOLDER WAS INVESTIGATED BY THE MANUFACTURING SITE. THE PURPOSE OF THIS INVESTIGATION IS TO INVESTIGATE A REPORT RECEIVED ASSOCIATED WITH AN UNKNOWN LOT OF CARPUJECT HOLDER. CALLER STATES THAT THEIR HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. AS THERE IS NO DEFECT OR FAILURE BEING REPORTED, A ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WILL NOT BE PERFORMED SINCE THE END USER IS ONLY INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM. INFORMATION REGARDING HOW TO USE THE CARPUJECT AND CARPUJECT HOLDERS CAN BE FOUND IN VARIOUS LOCATIONS: INSTRUCTIONS FOR USE OF CARPUJECTS WITH HOLDER ARE AVAILABLE AT PFIZERPRO.COM. A CARPUJECT TRAINING POSTER, BROCHURES, AND PRODUCT DEMONSTRATION VIDEO CAN BE FOUND AT "READYTOUSE.PFIZERPRO.COM." THE READY-TO-USE (RTU) DELIVERY SYSTEM LEARNING WEBSITE, "LEARNPFIZERRTU.COM," PROVIDES: OVERVIEW OF PFIZER HOSPITAL READY-TO-USE PRODUCTS (INCLUDING THE CARPUJECTS AND HOLDERS). VIDEOS DEMONSTRATING USE INTERACTIVE KNOWLEDGE CHECKS TO REINFORCE LEARNINGS. LINKS TO TOOLS AND RESOURCES NO COMPLAINT SAMPLES NOR PICTURES WERE RECEIVED OR REQUESTED TO ASSIST IN THE INVESTIGATION AS A MANUFACTURE DEFECT IS NOT BEING REPORTED. THE BATCH RECORD, LOT TRENDING, LOT INVESTIGATION QUERY, MANUFACTURE PROCESS TREND QUERY, AND APRR WERE NOT PERFORMED AS THERE IS NOT A MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT AND A LOT NUMBER WAS NOT PROVIDED. COMPLAINT SUB-CLASS TRENDING WAS PERFORMED FOR NON-DEFECT - LABELING UNCLEAR/CONFUSING/REQUIRES IMPROVEMENT FOR THE CARPUJECT/CARPUJECT HOLDER PRODUCT WITH 16 INVESTIGATIONS BEING RETURNED FOR THE TWO-YEAR QUERY TIME FRAME. PER THE DEFINED CRITERIA NO TREND WAS IDENTIFIED THEREFORE, THIS EVENT WILL NOT BE ELEVATED TO COMPLAINT MANAGEMENT REVIEW BOARD (CMRB). THE FINAL SCOPE WILL BE LIMITED TO AN UNKNOWN LOT NUMBER OF CARPUJECT HOLDER AS THERE IS NOT A REPORTED MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT, INSTEAD THE END USER WAS INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM SAFELY AND EFFECTIVELY. NO FURTHER INVESTIGATION IS REQUIRED. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THIS COMPLAINT WAS ALSO INVESTIGATED BY DEVICE ENGINEERING. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (B)(4), VERSION # (5.0). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 30DEC2024 FOR SOFTWARE MEDICAL DEVICE: INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURE SITE CONCLUSION. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. DEVICE ENGINEERING CONCLUSION. THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, IFU - UNCLEAR WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS ((B)(4), VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (08NOV2024): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (18NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM MALFUNCTION TO NOT DEVICE RELATED. THIS CASE HAS BEEN CONSIDERED INVALID AS NO AE. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM NOT DEVICE RELATED, TO VALID FOR MALFUNCTION. FOLLOW-UP (30DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED INVESTIGATION RESULTS.
EVENT [PREFERRED TERM], DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [DEVICE DIFFICULT TO USE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM AND PRODUCT QUALITY GROUP. THE REPORT REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), OUTCOME "UNKNOWN", DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (PRIVACY) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND MYSELF, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY IN-SERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS-ON IN-SERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT. THE REPORTER CONSIDERED "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" ASSOCIATED TO CARPUJECT HOLDER. CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY COMPLETE DATE(GMT): 18NOV2024. MDCP INVESTIGATION SUMMARY AND CONCLUSION: THIS COMPLAINT OF WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY INSERVICE MATERIALS AVAILABLE? FOR CARPUJECT HOLDER WAS INVESTIGATED BY THE MANUFACTURING SITE. THE PURPOSE OF THIS INVESTIGATION IS TO INVESTIGATE A REPORT RECEIVED ASSOCIATED WITH AN UNKNOWN LOT OF CARPUJECT HOLDER. CALLER STATES THAT THEIR HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. AS THERE IS NO DEFECT OR FAILURE BEING REPORTED, A ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WILL NOT BE PERFORMED SINCE THE END USER IS ONLY INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM. INFORMATION REGARDING HOW TO USE THE CARPUJECT AND CARPUJECT HOLDERS CAN BE FOUND IN VARIOUS LOCATIONS: INSTRUCTIONS FOR USE OF CARPUJECTS WITH HOLDER ARE AVAILABLE AT PFIZERPRO.COM. A CARPUJECT TRAINING POSTER, BROCHURES, AND PRODUCT DEMONSTRATION VIDEO CAN BE FOUND AT "READYTOUSE.PFIZERPRO.COM." THE READY-TO-USE (RTU) DELIVERY SYSTEM LEARNING WEBSITE, "LEARNPFIZERRTU.COM," PROVIDES: OVERVIEW OF PFIZER HOSPITAL READY-TO-USE PRODUCTS (INCLUDING THE CARPUJECTS AND HOLDERS). VIDEOS DEMONSTRATING USE INTERACTIVE KNOWLEDGE CHECKS TO REINFORCE LEARNINGS. LINKS TO TOOLS AND RESOURCES NO COMPLAINT SAMPLES NOR PICTURES WERE RECEIVED OR REQUESTED TO ASSIST IN THE INVESTIGATION AS A MANUFACTURE DEFECT IS NOT BEING REPORTED. THE BATCH RECORD, LOT TRENDING, LOT INVESTIGATION QUERY, MANUFACTURE PROCESS TREND QUERY, AND APRR WERE NOT PERFORMED AS THERE IS NOT A MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT AND A LOT NUMBER WAS NOT PROVIDED. COMPLAINT SUB-CLASS TRENDING WAS PERFORMED FOR NON-DEFECT - LABELING UNCLEAR/CONFUSING/REQUIRES IMPROVEMENT FOR THE CARPUJECT/CARPUJECT HOLDER PRODUCT WITH 16 INVESTIGATIONS BEING RETURNED FOR THE TWO-YEAR QUERY TIME FRAME. PER THE DEFINED CRITERIA NO TREND WAS IDENTIFIED THEREFORE, THIS EVENT WILL NOT BE ELEVATED TO COMPLAINT MANAGEMENT REVIEW BOARD (CMRB). THE FINAL SCOPE WILL BE LIMITED TO AN UNKNOWN LOT NUMBER OF CARPUJECT HOLDER AS THERE IS NOT A REPORTED MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT, INSTEAD THE END USER WAS INQUIRING ABOUT HOW TO USE THE CARPUJECT HOLDER SYSTEM SAFELY AND EFFECTIVELY. NO FURTHER INVESTIGATION IS REQUIRED. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THIS COMPLAINT WAS ALSO INVESTIGATED BY DEVICE ENGINEERING. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (B)(4), VERSION # (5.0)). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6)2024 FOR CARPUJECT HOLDER: INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURE SITE CONCLUSION. THE COMPLAINT FOR THE INSTRUCTIONS WERE UNCLEAR AND REQUIRED IMPROVEMENT WAS INVESTIGATED FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. DEVICE ENGINEERING CONCLUSION. THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, IFU - UNCLEAR WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (B)(4), VERSION # (5.0). ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED WITHIN THE HAZARD ANALYSIS. AND FOR THIS COMPLAINT THERE ARE NO APPLICABLE HAZARDS SINCE THE COMPLAINT RELATES TO SIMULATED USE IN A TRAINING ENVIRONMENT AND DID NOT CAUSE ANY HAZARD TO THE PATIENT. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (08NOV2024): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (18NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM MALFUNCTION TO NOT DEVICE RELATED. THIS CASE HAS BEEN CONSIDERED INVALID AS NO AE. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: REPORTABILITY ASSESSMENT CHANGED FROM NOT DEVICE RELATED, TO VALID FOR MALFUNCTION. FOLLOW-UP (30DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED INVESTIGATION RESULTS. AMENDMENT: THIS FOLLOW-UP IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: SUSPECT PRODUCT INFORMATION UPDATED.
EVENT VERBATIM [PREFERRED TERM] DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE [DEVICE DIFFICULT TO USE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A NURSE FROM MEDICAL INFORMATION TEAM. THE REPORTER REPORTED COMPLAINT ABOUT CARPUJECT HOLDER (CARPUJECT HOLDER). THE RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE DIFFICULT TO USE (NON-SERIOUS), DESCRIBED AS "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE". CAUSALITY FOR "DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: THE NURSE REPORTED THAT "OUR FACILITY (ESCAMBIA COUNTY JAIL) HAS RECENTLY BEGUN USING THE CARPUJECT SYSTEM. OUR STAFF, AND MYSELF, ARE HAVING A DIFFICULT TIME EFFECTIVELY AND SAFELY USING THE CARPUJECT SYSTEM. WE HAVE ATTEMPTED TO HANDLE, INSPECT AND MANIPULATE THE DEVICE IN ORDER TO BECOME FAMILIAR WITH IT AND IT'S USE BUT WE ARE FINDING THAT DIFFICULT AND UNSAFE TO DO WITH AN EMPTY MEDICATION VIAL AND THE CARPUJECT SYRINGE. DO YOU HAVE A TRAINING SET AVAILABLE FOR CLINICIANS TO USE FOR A FACILITY INSERVICE? ARE THERE ANY INSERVICE MATERIALS AVAILABLE? I.E: VIDEOS, PRINT OUTS, POWER POINTS ETC. THIS WOULD BE VERY HELPFUL AND WOULD ALLOW STAFF THE MATERIALS NEEDED FOR A HANDS ON INSERVICE OF THE SYSTEM. WE ANTICIPATE HAVING INSERVICES FOR 7-8 CLINICIANS AT A TIME ON EACH SHIFT.:
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2279780 | CARPUJECT HOLDER | DEVICE DELIVERY AID; CLASS I | IQG | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |