BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 8MM 90 BX 450 MO

    MDR report key: 22535700 · Received July 17, 2025

    Report

    Report Number
    3024508819-2025-00266
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Report Date
    July 17, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    30383017829033
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 1ST 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

    CONSUMER REPORTED THE NEEDLE BROKE IN HER SITE AFTER INJECTION. WAS ABLE TO REMOVE ON HER OWN. NO MEDICAL ATTENTION NEEDED. DENIED REUSE OF NEEDLES. FEELS THE EMBECTA BRAND IS INFERIOR TO BD. INFORMED CALLER SEVERAL TIMES WE ARE THE SAME. SENDING MAILING KIT. LOT # 5042112. CATALOG# 328290 EMBECTA. DATE OF EVENT UNKNOWN LAST WEEK. SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748867 SYRINGE 0.5ML 8MM 90 BX 450 MO Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328290 5042112 30383017829033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown