BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FLU+¿ SYRINGE

    MDR report key: 12474491 · Received September 15, 2021

    Report

    Report Number
    3002682307-2021-00487
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER: 2103419. 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. THE RETAINED SAMPLES WERE EVALUATED AND NO SIGNS OF LEAKAGE WERE IDENTIFIED. PER THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. BASED ON THE PROVIDED CUSTOMER FEEDBACK, IT IS POSSIBLE THAT THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT FROM THE MANUFACTURING PROCESS; HOWEVER, WITHOUT THE SAMPLE THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD FLU+¿ SYRINGE THERE WAS LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "COVID19 VACCINE LEAKED BEHIND THE PLUNGER WHILE PREPARING SYRINGE FOR COVID19 VACCINATION. TWO OR THREE TIMES THE SITUATION HAPPENED AND THE VACCINE WAS DISCARDED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHEN USING THE BD FLU+¿ SYRINGE THERE WAS LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "COVID19 VACCINE LEAKED BEHIND THE PLUNGER WHILE PREPARING SYRINGE FOR COVID19 VACCINATION. TWO OR THREE TIMES THE SITUATION HAPPENED AND THE VACCINE WAS DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371786 BD FLU+¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown