BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25127819 · Received May 8, 2026

    Report

    Report Number
    3003152976-2026-00207
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 22, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS REPORTED A COMPLAINT REGARDING ARTICLE 300865 BD PLASTIPAK SYRINGE, 3 PIECE, LUER LOCK BOX OF 60. THE CUSTOMER ORDERED 10 BOXES OF THIS ARTICLE. 240 SYRINGES ARRIVED DAMAGED. THE OUTER BOX WAS INTACT. HOWEVER, THE SYRINGES INSIDE WERE BENT AND LEAKING. NOTED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605157 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2512057 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown