BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNDISCLOSED 5ML SYRINGE

    MDR report key: 18418401 · Received December 29, 2023

    Report

    Report Number
    2243072-2023-02256
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    April 4, 2023
    Report Date
    December 20, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN. D. THE MATERIAL AND/OR LOT NUMBER 306594/210791 PROVIDED HAVE NOT BEEN FOUND AND/OR CANNOT/HAVE NOT BE/BEEN VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNDISCLOSED 5ML SYRINGE WAS FOUND WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PRIOR TO USING A 5 ML SYRINGE TO ADD MEDICATION ON (B)(6) 2023, THE NURSE NOTICED A WHITE UNKNOWN SUBSTANCE INSIDE AND REPLACED THE SYRINGE WITH A NEW ONE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245443 BD UNDISCLOSED 5ML SYRINGE SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown