BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 8776861 · Received July 10, 2019

    Report

    Report Number
    1024879-2019-01157
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686563
    PMA / PMN Number
    K011984
    Removal / Correction Number
    PAS-19-1567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-07/22/2019-009-R. 1. RECALL SUMMARY BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR CERTAIN LOTS OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG# 368656. BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. 2. PRODUCT AND SCOPE BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG NUMBER 368356, FOR THE FOLLOWING 12 LOTS: 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 LOTS NOT INCLUDED IN THE SCOPE OF THE RECALL ARE NOT AFFECTED. 3. DESCRIPTION OF ISSUE BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. BARREL SEPARATION MAY RESULT IN LEAKAGE OF BLOOD OR AN EXPOSED NEEDLE, POTENTIALLY RESULTING IN EXPOSURE TO BLOOD BORNE PATHOGENS. BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM. 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE PER 806 # 2243072-07/22/2019-009-R DATED AUGUST 2, 2019, THERE WERE A TOTAL OF 33 COMPLAINTS AND 31 MDRS WITHIN SCOPE. COMPLAINT: (B)(4); MDR: 1024879-2019-00960. COMPLAINT: (B)(4); MDR: 1024879-2019-00981. COMPLAINT: (B)(4); MDR: 1024879-2019-00975. COMPLAINT: (B)(4); MDR: 1024879-2019-00991. COMPLAINT: (B)(4); MDR: 1024879-2019-01005. COMPLAINT: (B)(4); MDR: 1024879-2019-00984. COMPLAINT: (B)(4); MDR: 1024879-2019-01038. COMPLAINT: (B)(4); MDR: 1024879-2019-01059. COMPLAINT: (B)(4); MDR: 1024879-2019-01071. COMPLAINT: (B)(4); MDR: 1024879-2019-01064. COMPLAINT: 1(B)(4); MDR: 1024879-2019-01094. COMPLAINT: (B)(4); MDR: 1024879-2019-01076. COMPLAINT: (B)(4); MDR: 1024879-2019-01107. COMPLAINT: 1010746; MDR: 1024879-2019-01107. COMPLAINT: 1013450; MDR: 1024879-2019-01091. COMPLAINT: (B)(4); MDR: 1024879-2019-01143. COMPLAINT: (B)(4); MDR: 1024879-2019-01130. COMPLAINT: (B)(4); MDR: 1024879-2019-01147. COMPLAINT:(B)(4); MDR: 1024879-2019-01157. COMPLAINT: (B)(4); MDR: 1024879-2019-01156. COMPLAINT: (B)(4); MDR: 1024879-2019-01163. COMPLAINT: (B)(4); MDR: 1024879-2019-01237. COMPLAINT: (B)(4); MDR: 1024879-2019-01195. COMPLAINT: (B)(4); MDR: 1024879-2019-01218. COMPLAINT: (B)(4); MDR: 1024879-2019-01116. COMPLAINT: (B)(4); MDR: 1024879-2019-01224. COMPLAINT: (B)(4); MDR: 1024879-2019-01197. COMPLAINT: (B)(4); MDR: 1024879-2019-01273. COMPLAINT: (B)(4); MDR: 1024879-2019-01304. COMPLAINT: (B)(4); MDR: 1024879-2019-01265. COMPLAINT: (B)(4); MDR: 1024879-2019-01303. COMPLAINT: (B)(4); MDR: 1024879-2019-01288. COMPLAINT: (B)(4); MDR: 1024879-2019-01288. 5. HHE SUMMARY: THE HHE CONSIDERED THE POTENTIAL HAZARDS, HARMS, SEVERITIES, AND LIKELIHOOD OF OCCURRENCE RELATED TO THE PRODUCT, SPECIFICALLY THE REPORTED ISSUE REGARDING THE SAFETY MECHANISM NOT FUNCTIONING AS INTENDED. EXPOSURE TO BLOOD, INCLUDING BLOODBORNE PATHOGENS REPRESENTS A POTENTIAL FOR IMMEDIATE AND LONG-TERM HEALTH CONSEQUENCE TO THE HEALTHCARE WORKER. THIS WOULD BE IN THE PRESENCE OF A NEEDLESTICK INJURY TO THE HCW AFTER THE DEVICE WAS USED ON A PATIENT AS WELL AS BLOOD LEAKAGE FROM THE DEVICE WHICH COULD COME IN DIRECT CONTACT WITH THE UNPROTECTED SKIN (NOT FOLLOWING PROPER PPE PROCEDURE) OF THE HCW COLLECTING THE BLOOD. THE LIKELIHOOD OF HEALTH RISK FROM THE USAGE OF UNNECESSARY POST-EXPOSURE PROPHYLAXIS (PEP) AND LABORATORY TESTING DUE TO CONTAMINATED NEEDLE STICK INJURY OR EXPOSURE OF NON-INTACT SKIN IS CONSIDERED MINIMAL. THIS IS SUPPORTED BY DOCUMENTED LITERATURE THAT INDICATES GOOD EFFICACY OF PEP BEING OBSERVED WITH NO SEROCONVERSION. GENERAL AWARENESS FOR THE USE OF SHARPS AS WELL AS THE USE OF GENERAL SAFETY PRECAUTIONS IS KNOWN TO HELP DECREASE THE LIKELIHOOD OF EXPOSURE TO BLOODBORNE PATHOGENS. 6. INVESTIGATION SUMMARY: ROOT CAUSE INVESTIGATION INDICATES A MIS-ALIGNMENT OF TOOLING TO LOAD AND ASSEMBLE COMPONENTS IN THE ASSEMBLY LINE. BD PAS HAS INITIATED CAPA 982194 TO FURTHER INVESTIGATE THIS ISSUE, AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. 7. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z#: PLEASE REFERENCE BD RECALL # PAS-19-1567.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AS OF (B)(6) 2019 THIS COMPLAINT IS UNDER THE SCOPE OF FIELD ACTION # PAS (B)(4): BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA #982194 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA #982194 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION:ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA #982194. THE CAPA HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBIAGE RECEIVED, -PRODUCT # 368656 LOT # 9091626 CAME APART WHEN DRAWING BLOOD. ADDITIONAL INFORMATION RECEIVED, -THAT IS THE CORRECT PRODUCT NUMBER. THE ISSUES STARTED TO OCCUR APPROXIMATELY TWO WEEKS AGO GIVE OR TAKE A FEW DAYS. I WAS MADE AWARE OF THE SITUATION LAST FRIDAY THE 21ST OF JUNE. SINCE THEN, FOUR PHLEBOTOMISTS HAVE COME FORWARD TO COMPLAIN ABOUT BUTTERFLIES COMING APART EITHER PRIOR TO PERFORMING BLOOD DRAWS OR AT THE END WHEN ENGAGING THE SAFETY BUTTON. I HAVE THE PRODUCT IN QUESTION BUT UNFORTUNATELY I DO NOT HAVE PICTURES AT THIS TIME. I WILL BE CC-ING MY DIRECTOR AND OUR QUALITY CONTROL MANAGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBIAGE RECEIVED, PRODUCT # 368656, LOT # 9091626, CAME APART WHEN DRAWING BLOOD. ADDITIONAL INFORMATION RECEIVED, THAT IS THE CORRECT PRODUCT NUMBER. THE ISSUES STARTED TO OCCUR APPROXIMATELY TWO WEEKS AGO GIVE OR TAKE A FEW DAYS. I WAS MADE AWARE OF THE SITUATION LAST FRIDAY THE (B)(6). SINCE THEN, FOUR PHLEBOTOMISTS HAVE COME FORWARD TO COMPLAIN ABOUT BUTTERFLIES COMING APART EITHER PRIOR TO PERFORMING BLOOD DRAWS OR AT THE END WHEN ENGAGING THE SAFETY BUTTON. I HAVE THE PRODUCT IN QUESTION BUT UNFORTUNATELY I DO NOT HAVE PICTURES AT THIS TIME. I WILL BE CC-ING MY DIRECTOR AND OUR QUALITY CONTROL MANAGER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI, JKA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBIAGE RECEIVED, PRODUCT # 368656, LOT # 9091626 CAME APART WHEN DRAWING BLOOD. ADDITIONAL INFORMATION RECEIVED, THAT IS THE CORRECT PRODUCT NUMBER. THE ISSUES STARTED TO OCCUR APPROXIMATELY TWO WEEKS AGO GIVE OR TAKE A FEW DAYS. I WAS MADE AWARE OF THE SITUATION LAST FRIDAY THE 21ST OF JUNE. SINCE THEN, FOUR PHLEBOTOMISTS HAVE COME FORWARD TO COMPLAIN ABOUT BUTTERFLIES COMING APART EITHER PRIOR TO PERFORMING BLOOD DRAWS OR AT THE END WHEN ENGAGING THE SAFETY BUTTON. I HAVE THE PRODUCT IN QUESTION BUT UNFORTUNATELY I DO NOT HAVE PICTURES AT THIS TIME. I WILL BE CC-ING MY DIRECTOR AND OUR QUALITY CONTROL MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572685 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON & CO., (BD) 9091626 50382903686563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other