BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25310789 · Received May 27, 2026

    Report

    Report Number
    3003152976-2026-00249
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 18, 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
    UK
    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

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT: I AM EMAILING REGARDING A RECENT BATCH OF 50ML SYRINGES. UPON OPENING THE SYRINGES, WE HAVE IDENTIFIED AN EXCESS OF WHAT SEEMS TO BE OIL RESIDUE IN THE SYRINGES. WE USE YOUR SYRINGES TO MANUFACTURE SACT, MAB AND CIVA TREATMENTS. WHEN DID THE INCIDENT OCCUR? BEFORE USE. SHORT DESCRIPTION: UPON OPENING THE SYRINGES, IDENTIFIED AN EXCESS OF WHAT SEEMS TO BE OIL RESIDUE IN THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440612 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2511043 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1