BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG

    MDR report key: 18823428 · Received March 2, 2024

    Report

    Report Number
    1920898-2024-05044
    Event Type
    Malfunction
    Date Received
    March 2, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00382903230013
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NOT AVAILABLE YET. ONCE THE INVESTIGATION IS COMPLETED. INVESTIGATIONS SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). 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

    PET OWNER REPORTED FINDING ONE SYRINGE WITH A HOLE IN THE BARREL PRIOR TO INJECTION. STATED, SHE NOTICED THE HOLE WHEN THE BARREL WAS LEAKING AND SHE HAD A DIFFICULT TIME DRAWING. STATED, SHE FOUND A SECOND SYRINGE MISSING THE PLUNGER ROD PRIOR TO INJECTION. LOT: 2213881 CATALOG: 323001 DATE OF EVENT: UNKNOWN SAMPLES: YES CALLING BACK WITH LOT NUMBER CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137405 VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 323001 2213881 00382903230013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown