BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 14 PACK

    MDR report key: 20085531 · Received August 28, 2024

    Report

    Report Number
    3027605735-2024-00060
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 9, 2024
    Report Date
    November 12, 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

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED, INVESTIGATION WAS PERFORMED ON THE RETAIN SAMPLES AND NO ISSUES WERE OBSERVED 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

    THE CUSTOMER CALLED TO REPORT THAT NEEDLE LEAKAGE AFTER INJECTION FOR PATIENT. PATIENTS USED MICRO-FINE NEEDLE FOR MORE THAN 20 YEARS AND HAD NEVER LEAKAGE BEFORE. MATERIAL CODE 329490, LOT NUMBER 1232482. IT WAS CONFIRMED THAT THE PATIENT OPERATED INCORRECTLY: THE PATIENT NEVER EXPEL AIR OF THE NEEDLE AND REUSED THE NEEDLE, AND THE PATIENT HAD SUBCUTANEOUS NODULES. CALL CENTER INTRODUCED THE DETAILED OPERATION METHOD AND PRECAUTIONS TO THE CUSTOMER. THE CUSTOMER SAID THAT PERSONAL INFORMATION WAS INCONVENIENT TO DISCLOSE SAMPLE AVAILABILITY: NO SAMPLE AVAILABILITY DETAILS: NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158607 PEN NEEDLE 31GX5MM 14 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329490 1232482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown