BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 32G X 4MM 3B TW 50CT

    MDR report key: 21016694 · Received December 26, 2024

    Report

    Report Number
    3027605735-2024-00128
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 1, 2024
    Report Date
    February 18, 2025
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SPOUSE OF CONSUMER REPORTED THAT THE PEN NEEDLES WILL NOT ATTACH. SHE STATED THAT THE NEEDLES KEEP SPINNING AS SHE IS TRYING TO TIGHTEN THEM BUT WILL NOT ATTACH. LOT #: 3031919. CATALOG #: 320618. DATE OF EVENT: 12-1-2024. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88420 PN RELION 32G X 4MM 3B TW 50CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 320618 3031919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male