BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML SYRINGE

    MDR report key: 11646340 · Received April 9, 2021

    Report

    Report Number
    3002682307-2021-00128
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 4, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 3 BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER, AND DEFECTIVE/DAMAGED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INJECTING, LIQUID COMES OUT BETWEEN PLUNGER AND BARREL. D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-09. H3: DEVICE RETURNED TO MANUF.?: YES. H6: DEVICE EVAL BY MANUFACTURER?: YES. H6: IMDRF ANNEX B GRID: B01, B14. H6: IMDRF ANNEX C CODE: C16. IMDRF ANNEX D CODE: D03. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011108. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012162. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011123. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWELVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER LIP COMPONENTS. ELEVEN REFERENCE SAMPLES WERE ALSO RETURNED; HOWEVER, THESE SAMPLES DID NOT PRESENT ANY SIGNS OF LEAKAGE. PLUNGER LIP DAMAGE CAN BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. A QUALITY PROCESS HAS BEEN INITIATED WITH THE AIM OF REDUCING THIS TYPE OF DEFECT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: AFTER THE EVALUATION OF THE RECEIVED AFFECTED SAMPLES, WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER, AND DEFECTIVE/DAMAGED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INJECTING, LIQUID COMES OUT BETWEEN PLUNGER AND BARREL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2012162. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-10. MEDICAL DEVICE LOT #: 2011108 . MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-10-29. MEDICAL DEVICE LOT #: 2011123. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-03. 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 3 BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INJECTING, LIQUID COMES OUT BETWEEN PLUNGER AND BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541901 BD DISCARDIT II 2 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2011123

    Patients

    Seq Age Sex Outcome Treatment
    1