BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1IN

    MDR report key: 9900892 · Received March 30, 2020

    Report

    Report Number
    3002682307-2020-00116
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1910516 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS NEITHER A PHYSICAL SAMPLE NOR A PICTURE SAMPLE WAS AVAILABLE FOR RETURN, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1IN LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING DISCARDIT SYRINGES SPINAL MEDICINE GETTING LEAK".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1IN LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING DISCARDIT SYRINGES SPINAL MEDICINE GETTING LEAK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365315 SYRINGE S2 10ML 21GA 1IN SYRINGE FMF BECTON DICKINSON, S.A. 1910516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other