BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24641117 · Received March 19, 2026

    Report

    Report Number
    3003152976-2026-00141
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 13, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. APPLICABLE 510K NUMBERS ARE K182589;K980987. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE: THE CUSTOMER DETECTED AIR IN THE SYRINGE DURING ONGOING USE WITH A PATIENT, WHEN CHANGING THE SYRINGE, THE NURSE EXPERIENCED MEDICATION LEAKING AROUND THE PISTON. ADDITIONAL INFORMATION PROVIDED: WE HAVE NOT OBSERVED ANY PATIENT INJURY OR NEED FOR MEDICAL INTERVENTION RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346917 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2507112 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1