BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 24551441 · Received March 9, 2026

    Report

    Report Number
    9610847-2026-00096
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 BY CUSTOMER THAT TWO OF THEM HAVE THE SAME ISSUE WITH THE ADDITION OF HAVING ALSO PARTICLES INSIDE THE SYRINGE RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CASE DESCRIPTION: CUSTOMER STATES THAT THEY RECEIVED TWO DIFFERENT BOXES FROM TWO DIFFERENT LOT NUMBERS WITH A SIMILAR ISSUE. WITH THE FIRST BOX (LOT# 3139736), THREE OF THE SYRINGES HAVE PARTICLES MELTED INTO THE PLASTIC. WITH THE SECOND BOX (LOT# 3150714), TWO OF THEM HAVE THE SAME ISSUE WITH THE ADDITION OF HAVING ALSO PARTICLES INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20084 SYRINGE 50CC LL TIP CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3150714 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown