BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 22073941 · Received May 22, 2025

    Report

    Report Number
    3024508819-2025-00239
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 22, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 3RD COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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.

    Description of Event or Problem · 0

    VERBATIM: SILICONE VESICLES IN THE VITREOUS BODY AFTER INTRAVITREAL INJECTION OF VABYSMO 6MG/0.05ML ON (B)(6) 2025. MEDICAL DEVICE BD MICROFINE+5MM NEEDLES SERIAL / BATCH NUMBER: (B)(6) / 4100003 BFARM CASE NUMBER: (B)(4). YOUR REFERENCE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513844 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324824 4100003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown