BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 5B 28CT

    MDR report key: 19264387 · Received May 7, 2024

    Report

    Report Number
    3027605735-2024-00006
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 30, 2024
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS MADE TO SECTIONS D3 (COUNTRY TYPE & COUNTRY), G1 (STATE), AND H6 (TYPE OF INVESTIGATION & 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

    REPRESENTATIVE REPORTED THAT THE BATCH NUMBER OF THE LARGE BOX OF 5MM NEEDLES WITH PRODUCT NUMBER 329496 WAS INCONSISTENT WITH THE BATCH NUMBER OF SMALL BOX. BATCH NUMBER OF LARGE BOX IS 2182015, CONTAINING 50 BOXES OF 28CT NEEDLES, BATCH NUMBER OF SMALL BOX IS 2182016. SAMPLES DO NOT NEED TO BE RETURNED, AND THE RELATED PRODUCTS HAD BEEN SOLD BY DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670962 PEN NEEDLE 31GX5MM 5B 28CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329496 2182015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown