BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL BNS

    MDR report key: 12550595 · Received September 29, 2021

    Report

    Report Number
    1213809-2021-00681
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1188398. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-07-07. MEDICAL DEVICE LOT #: 1180401. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-06-29. 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 5ML LL BNS HAD FOREIGN MATTER. THIS OCCURRED ON 5600 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED "OIL IN THE BLACK PLUNGER PORTION, ¿LUBRICATION SUBSTANCE ON TIP.¿"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446353 SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1