BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FLU+ SYRINGE

    MDR report key: 11925842 · Received June 2, 2021

    Report

    Report Number
    3002682307-2021-00228
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2101413. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF LEAKAGE WERE OBSERVED. WITHOUT THE SAMPLE IT IS NOT POSSIBLE TO DETERMINE A CAUSE FOR THE INCIDENT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD FLU+¿ SYRINGE LEAKED VACCINATION MEDICINE FROM THE NEEDLE TIP AFTER DRAWING IT UP. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A NUMBER OF COMPLAINTS ABOUT LEAKAGE FROM THE NEEDLE. IT WAS REPORTED THAT AFTER DRAWING UP THE DOSE, A DROP OF VACCINE SOMETIMES LEAKS FROM THE NEEDLE TIP WITHOUT ANY PRESSURE BEING APPLIED TO THE PLUNGER".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD FLU+¿ SYRINGE LEAKED VACCINATION MEDICINE FROM THE NEEDLE TIP AFTER DRAWING IT UP. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A NUMBER OF COMPLAINTS ABOUT LEAKAGE FROM THE NEEDLE. IT WAS REPORTED THAT AFTER DRAWING UP THE DOSE, A DROP OF VACCINE SOMETIMES LEAKS FROM THE NEEDLE TIP WITHOUT ANY PRESSURE BEING APPLIED TO THE PLUNGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821622 BD FLU+ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101413

    Patients

    Seq Age Sex Outcome Treatment
    1