BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24423686 · Received February 23, 2026

    Report

    Report Number
    3003152976-2026-00089
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    February 10, 2026
    Report Date
    February 13, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SILICONE VISIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT EXCESS LUBRICATION, PARTICLES INSIDE AND ON TOP OF PLUNGER, FIBRES, SOLID BUBBLES AND DAMAGED EXTERIOR. NAME: PLASTIPAK 50ML SYRINGE 3 PIECE CONCENTRIC LUER LOCK, PO: (B)(4), LOT: 2507054, EXPIRY: 30/06/2030, QUANTITY REJECTED: (B)(4) PIECES. 50ML ¿ FIBRES AND EXCESS LUBRICATION. 50ML ¿ EXCESS LUBRICATION AND SOLID BUBBLES. 50ML ¿ DAMAGED EXTERIOR. 50ML ¿ PARTICLES AND LUBRICATION. 50ML ¿ PARTICLES/FIBRES. 50ML - PARTICLES INSIDE AND ON TOP OF PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449347 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2507054 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1