BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 21334338 · Received February 7, 2025

    Report

    Report Number
    3003152976-2025-00047
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 16, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903006298
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE SUBMISSION OF THE INITIAL MDR, FURTHER SAMPLE ANALYSIS INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS NOT REPORTABLE TO THE FDA AS IT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. MFR#: 3003152976-2025-00047 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    WE WOULD LIKE TO INFORM YOU OF SEVERAL MALÉRIO'VIGILANCE DECLARATIONS, TRANSMITTED BY THE URCC REGARDING THESE MEDICAL DEVICES'. ON 08/01/2025, THE FOLLOWING MALFUNCTION WAS REPORTED TO US: "THAT DAY IN THE URCC, THE PREPARATION STAFF FOUND SMALL WHITE PIECES OF PLASTIC IN THE BARREL OF THE NEW SYRINGE (IN THE SPACE WHERE THE LIGUID IS ASPIRATED)? THE PLASTIC PIECES ARE SEEN BEFORE USE, WHEN OPENING THE STERILE PACKAGING OF THE 20ML BD TUER LOCK SYRINGE REF (B)(4), LOT 2410019 FAB 01/10/2024 EXP 30/09/2029...' ON 16/01/2025, WE WERE NOTIFIED OF THE FOLLOWING MALFUNCTION "PB WITH 2 BD SYRINGES: 20MI SYRINGE REF(B)(4) LOT 2410019 . PLUNGER VISUALLY DIRTY (ANCHOR OR DIRT??).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124950 SYRINGE 20ML LL 120/PKG SYRINGE, PISTON FMF BECTON DICKINSON 2410019 00382903006298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown