BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25194268 · Received May 15, 2026

    Report

    Report Number
    3003152976-2026-00236
    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
    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. 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: IT WAS REPORTED THAT THE SAME LEVEL OF OILY RESIDUE HAS NOW BEEN IDENTIFIED IN A SYRINGE FROM ANOTHER BATCH OF 50ML SYRINGES: PRODUCT: BD 50 ML SYRINGES BATCH/LOT NUMBER: 2603021 BATCH EXP: 28/02/2031 QUANTITY AFFECTED: UNKNOWN AT PRESENT I WOULD APPRECIATE A QUICK RESPONSE, GIVEN THIS HAS NOW IMPACTED MULTIPLE BATCHES AND MAY HAVE AN IMPACT ON MANUFACTURING CAPABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32311 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2603021 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown