BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL 1/2ML INS SYR 28GX1/2"

    MDR report key: 19291790 · Received May 10, 2024

    Report

    Report Number
    1035907-2024-00021
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    July 28, 2023
    Report Date
    May 10, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221260243
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER OUR INVESTIGATION: THERE HAVE BEEN NO SIMILAR CONFIRMED COMPLAINTS FOR THIS PRODUCT IN THE PAST YEAR VISUAL INSPECTION WAS PERFORMED ON 100PCS RETAINED SAMPLES WITH NO BENT NEEDLES OBSERVED AFTER OPENING THE NEEDLE CAP MAGNIFIED INSPECTION (20X) WAS PERFORMED ON 50PCS RETAINED SAMPLES WITH NO BENT NEEDLES OBSERVED. REVIEW OF IN PROCESS RECORDS DID NOT FIND ANY NONCONFORMITIES RELATING TO BENT NEEDLES. POTENTIAL CAUSES BUT CANNOT BE CONFIRMED DUE TO THE LACK OF THE RETURNED PRODUCT: MISHANDLING, NEEDLE REUSE, INCORRECT CAP REMOVAL, DEFECTS IN PRODUCTION PROCESS. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 0

    "ONE OF THE SYRINGES HAD A BENT NEEDLE AND SHE WAS UNABLE TO USE IT". IT WAS OBSERVED AFTER REMOVAL OF THE CAP. THERE ARE NO PHOTOGRAPHS AVAILABLE. THE SYRINGES WERE TO BE USED FOR LEUPROLIDE ACETATE INJECTION. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EVENTS AND IF THE PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530438 EXEL 1/2ML INS SYR 28GX1/2" INSULIN SYRINGE FMF EXELINT INTERNATIONAL, CO. 210822 00020221260243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown