BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 18570295 · Received January 24, 2024

    Report

    Report Number
    1920898-2024-05013
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 26, 2023
    Report Date
    April 19, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H3, DEVICE CODE. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, THE NEEDLE AND HUB SEPARATED AND IS STUCK INSIDE THE NEEDLE SHIELD. STATED, THERE IS NO EXPIRATION DATE ON THE BAG SHE'S USING AND DOES NOT KNOW HOW OLD THE SYRINGES ARE. 1 SYRINGE AFFECTED. LOT: 0083446 CATALOG: 328509 DATE OF EVENT: 2023-12-26 SAMPLE: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316902 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328509 0083446 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown