BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 20762582 · Received November 22, 2024

    Report

    Report Number
    3024508819-2024-00456
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 24, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS EMBC-25-0002-SA WAS OPENED TO ADDRESS THIS COMPLAINT.

    Description of Event or Problem · 0

    WHEN DID IT OCCUR? : BEFORE USE. NEEDLE INJURY: NO. OTHER TREATMENT: NO. WERE THE RETURNED ITEMS USED? : NO. RETURNED QUANTITY: 1 BAG. DETAILS OF THE EVENT (TIMELINE, HISTORY, ETC.): IN APRIL THIS YEAR, A VETERINARY HOSPITAL, A CLIENT OF OURS, CONTACTED US REGARDING 1 BAG WITH A DIFFERENT NUMBER OF GAUGES MIXED IN THE 12 BAGS OF PRODUCTS WHEN OPENED. BATCH #: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799096 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 326638 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown