BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML LL WITH CO-PACKED NEEDLE 26GX3/8'

    MDR report key: 22821673 · Received August 15, 2025

    Report

    Report Number
    1035907-2025-00033
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT LOT NUMBER WAS PROVIDED AS LOT # 230305. PER A PREVIOUS LOT INVESTIGATION FOR A DIFFERENT ISSUE. BATCH RECORDS AND FINAL INSPECTION RECORDS WERE REVIEWED WITH NO ABNORMALITIES NOTED. 5 RETAINED SAMPLES WERE TESTED. 1. VISUAL INSPECTION DID NOT NOTE ANY DEFECTS. 2. SIMULATED ASPIRATION AND INJECTION TEST DID NOT NOTE ANY DEFECTS. NO DEFECTS OR ABNORMALITIES WERE OBSERVED DURING RECORD REVIEW OR RETAINED SAMPLE TESTING. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 0

    REPORTER PROVIDED LOT NUMBER WAS INCORRECT AND DID NOT MATCH WITH THE PRODUCT. (B)(4).

    Description of Event or Problem · 0

    CALLER REPORTED "NEEDLE WILL NOT DRAW OUT INSULIN FROM VIAL." THERE WERE NO INJURY OR ADVERSE EVENTS REPORTED. TO RESOLVE THE ISSUE THE PATIENT SWITCHED TO MDI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295821 3ML LL WITH CO-PACKED NEEDLE 26GX3/8' SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 1001215 230305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown