BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 5B 28CT

    MDR report key: 20388616 · Received October 7, 2024

    Report

    Report Number
    3027605735-2024-00076
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 13, 2024
    Report Date
    December 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

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6), THE CUSTOMER CALLED TO REPORT THE NEEDLES THEY PURCHASED AND FOUND THAT THERE WAS NO PRODUCTION DATE AND EXPIRATION DATE ON THE OUTER PACKAGING OF ONE BOX. THE MATERIAL CODE IS 329497 AND THE LOT NUMBER IS 3073698. THE CUSTOMER SAID THAT THEY HAD CONTACTED THE SUPPLIER AND THE SUPPLIER ASKED THEM TO CALL 400 FOR A RETURN. THE CUSTOMER HOPED TO RETURN A BOX OF NORMAL PRODUCTS. THE PROBLEMATIC NEEDLES WAS MAILED AND PHOTOS WAS PROVIDED. NO CUSTOMER RESPONSE IS NEEDED. SAMPLE AVAILABILITY: YES. SAMPLE AVAILABILITY DETAILS: PICTURE/VIDEO AVAILABLE AND PHYSICAL SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547559 PEN NEEDLE 32GX4MM 5B 28CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329497 3073698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose