BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FLU+ SYRINGE

    MDR report key: 12147421 · Received July 9, 2021

    Report

    Report Number
    3002682307-2021-00314
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012414. 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 THIS INCIDENT, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF LEAKAGE WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VACCINE MEDICINE LEAKED FROM THE BOTTOM OF THE BD FLU+¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACCINE NOTED TO BE LEAKING OUT OF THE BOTTOM OF THE SYRINGE, NO INJURY, SYRINGE FILLED WITH VACCINE DISPOSED OF."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VACCINE MEDICINE LEAKED FROM THE BOTTOM OF THE BD FLU+¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACCINE NOTED TO BE LEAKING OUT OF THE BOTTOM OF THE SYRINGE, NO INJURY, SYRINGE FILLED WITH VACCINE DISPOSED OF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040640 BD FLU+ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012414

    Patients

    Seq Age Sex Outcome Treatment
    1