BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 14 PACK

    MDR report key: 21163105 · Received January 15, 2025

    Report

    Report Number
    3027605735-2025-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 15, 2025
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    10 PEN NEEDLES IMPACTED FROM LOT # 2062290. SEE SECTION C FOR ADDITIONAL INFORMATION. THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: 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

    THE CUSTOMER CALLED TO REPORT THAT HE BOUGHT NEEDLES ONLINE, ITEM NUMBER 329491, BATCH NUMBER 2062290. ABOUT 10 NEEDLES WERE FOUND TOO LONG AFTER INJECTED, AND BLEEDING OCCURRED OCCASIONALLY. THE CUSTOMER SAID THAT THE NEEDLES WERE ABOUT 8MM AFTER THE INJECTION, AND SUCH PROBLEM HAS OCCURRED FREQUENTLY RECENTLY. CALL CENTER THOUGHT THAT CANNULA MAY SEPARATED FROM HUB. THE CUSTOMER HOPES TO BE COMPENSATED AND FEEDBACK IN ACCORDANCE WITH THE CONSUMER RIGHTS PROTECTION LAW. ONLY ONE PROBLEMATIC NEEDLE WAS RETAINED, WHICH CAN BE MAILED, AND PHONE CALL RESPONSE IS REQUIRED IF ANY INVESTIGATION RESULTS. SAMPLE AVAILABILITY: YES. SAMPLE AVAILABILITY DETAILS: PHYSICAL SAMPLE AVAILABLE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166324 PEN NEEDLE 32GX4MM 14 PACK Needle, hypodermic, single lumen FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329491 2062290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male