BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM S/C U-100 RELION

    MDR report key: 22143176 · Received June 4, 2025

    Report

    Report Number
    3024508819-2025-00246
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    PET OWNER REPORTED SEVERAL ISSUES WITH SYRINGES. STATED, "SCALE MARKINGS/LINES ARE CROOKED" STATED, SOME "SCALE MARKINGS ARE MISSING" STATED, NEEDLE IS BENT BEFORE INJECTION LOT: 4282062, 4191020, 4233018 CATALOG: 328521 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626254 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328521 4282062 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown