BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24980389 · Received April 24, 2026

    Report

    Report Number
    3003152976-2026-00192
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 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
    GM
    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 HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? BEFORE USE. A LUBRICATING FILM HAS FORMED ON THE PISTON, CREATING A THIN, CONTINUOUS LAYER OF LUBRICANT ON ITS SURFACE. THIS FILM HELPS REDUCE FRICTION BETWEEN THE PISTON AND THE SURROUNDING COMPONENTS, ENSURES SMOOTHER MOVEMENT DURING OPERATION, AND PROTECTS THE PISTON FROM EXCESSIVE WEAR AND POTENTIAL DAMAGE CAUSED BY METAL-TO-METAL CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591194 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2602068 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1