BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25194127 · Received May 15, 2026

    Report

    Report Number
    3003152976-2026-00235
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 12, 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
    FI
    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. 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 INTIIAL REPORTER: IT WAS REPORTED THAT, PRESUMABLY, SILICONE FROM THE PLUNGER STICKS TO THE SYRINGE WHEN THE PLUNGER TOUCHES THE TOP OF THE SYRINGE. TRACES OF SILICONE REMAIN ON THE TOP OF THE SYRINGE. THERE APPEARS TO BE SO MUCH SILICONE ON THE PLUNGER THAT IT STICKS TO THE SYRINGE WHEN THE PLUNGER IS IN THE UP POSITION. THE SYRINGE IN QUESTION HAS NOT BEEN USED IN THE PREPARATION OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494291 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2510025 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown