BD SYRINGE NRFIT¿ LOK
Report
- Report Number
- 1213809-2024-00790
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 11, 2024
- Report Date
- January 28, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- QEH
- UDI-DI
- 00382904001742
- PMA / PMN Number
- K192538
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TWENTY-EIGHT SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SYRINGES WERE FOUND WITH NRFIT SCALE MARKINGS ON A LUER-LOK BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSES FOR THE MIXED PRODUCT DEFECT COULD BE ASSOCIATED WITH FAILURE TO PROPERLY CONTAIN ANY PREVIOUSLY CONVEYED PRODUCT PRIOR TO THE NRFIT RUN AND INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY. SITUATION ANALYSIS AND CORRECTIVE AND PREVENTATIVE ACTIONS WERE INITIATED WITH MULTIPLE CORRECTIVE ACTIONS IDENTIFIED AND IMPLEMENTED. ADDITIONALLY, A CORRECTIVE ACTION OPENED UNDER INTERNAL EXCEPTION WAS TO BETTER CONTROL THE PROCESS RELATED TO CONVEYED RAW MATERIALS. THESE CHANGES WILL BE DOCUMENTED IN UPDATES TO THE PROCESS CONTROL FORMS AND APPLICABLE WORK INSTRUCTIONS. OPERATORS AND SUPERVISORS SIGNED OFF TO THE MACHINERY AND LINE CLEARANCE DOCUMENTATION WERE RE-EDUCATED TO THE DOCUMENTATION VIA INTERNAL SYSTEM. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
PR 10940619 FOLLOW UP REPORT FOR DEVICE EVALUATION. POST INVESTIGATION FINDINGS REVEALED THE ADDITIONAL FAILURE OF STOPPER JAMMED / INSECURE. TWENTY-EIGHT SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SYRINGES WERE FOUND WITH NRFIT SCALE MARKINGS ON A LUER-LOK BARREL. BOTH PHOTOS SHOW TWO SYRINGES IN UNSEALED PACKAGES, ONE SYRINGE WITH THE LUER-LOK BARREL AND ONE SYRINGE HAVING THE STOPPER INSECURE TO THE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER INSECURE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. POTENTIAL ROOT CAUSES FOR THE MIXED PRODUCT DEFECT COULD BE ASSOCIATED WITH FAILURE TO PROPERLY CONTAIN ANY PREVIOUSLY CONVEYED PRODUCT PRIOR TO THE NRFIT RUN AND INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY. SITUATION ANALYSIS AND CORRECTIVE AND PREVENTATIVE ACTIONS WERE INITIATED WITH MULTIPLE CORRECTIVE ACTIONS IDENTIFIED AND IMPLEMENTED. ADDITIONALLY, A CORRECTIVE ACTION OPENED UNDER INTERNAL EXCEPTION WAS TO BETTER CONTROL THE PROCESS RELATED TO CONVEYED RAW MATERIALS. THESE CHANGES WILL BE DOCUMENTED IN UPDATES TO THE PROCESS CONTROL FORMS AND APPLICABLE WORK INSTRUCTIONS. OPERATORS AND SUPERVISORS SIGNED OFF TO THE MACHINERY AND LINE CLEARANCE DOCUMENTATION WERE RE-EDUCATED TO THE DOCUMENTATION VIA INTERNAL SYSTEM. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
(B)(4) FOLLOW UP REPORT FOR CORRECTION. THE EVENT / PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT / PRODUCT PROBLEM IS MIXED PRODUCT / LOTS. ANNEX A CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX A CODE SHOULD BE A2101 - DEVICE MARKINGS / LABELING PROBLEM.
NO ADDITIONAL INFORMATION WAS PROVIDED.
POST INVESTIGATION RESULTS INDICATE AN ADDITIONAL FAILURE OF "STOPPER JAMMED / INSECURE".
IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ LOK HAD A MOLDING DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: AFTER VISUAL INSPECTION, EVERY 2-3 SYRINGES (5 PCS. ON ONE STRAND) ARE AFFECTED BY THE PRODUCTION DEFECT. SEE PHOTOS FOR DETAILS, THE STAMP IS UNEVEN. WHEN DID THE INCIDENT OCCUR? BEFORE USE.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1611383 | BD SYRINGE NRFIT¿ LOK | PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT | QEH | BECTON DICKINSON MEDICAL SYSTEMS | 1041220 | 00382904001742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |