BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21384807 · Received February 14, 2025

    Report

    Report Number
    3027605735-2025-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Report Date
    March 14, 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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO. CORRECTION TO: H6 (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 2ND 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 REPORTED ON VOICE MESSAGE - WHEN TURNING THE PEN NEEDLE ONTO THE PEN, THE PEN NEEDLE JUST CLICK, CLICKS. DOES NOT FIT ON THE PEN. DC. LOT # UNKNOWN AT THIS TIME CATALOG# RELION PEN NEEDLE. NUMBER UNKNOWN AT THIS TIME. DATE OF EVENT UNKNOWN SAMPLE STATUS UNKNOWN. 1ST CALL BACK ATTEMPT MADE. LEFT MESSAGE ON CONSUMERS VOICE MESSAGE SYSTEM. DC. VCOYNE (B)(6) 2025 UPDATE/ADDITONAL INFORMATION - SEE ATTACHMENTS UPDATE 00022813 ITEM # 320618 RELION PEN NEEDLES LOT # 3031919 SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117387 N RELION 32G X 4MM 3B TW 50CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 000000000000320618 3031919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose