BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 19754747 · Received July 16, 2024

    Report

    Report Number
    3024508819-2024-00182
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Report Date
    October 8, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS) 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 CALLED TO INQUIRE ABOUT EXPIRATION DATE ON SYRINGES, SHE STATED THAT THERE WAS NO EXPIRATION DATE ON THE BOX. LOT #: 2030485; CATALOG #: 328431; DATE OF EVENT: N/A; SAMPLES: N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739184 SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328431 2030485 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female