BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 7 PACK

    MDR report key: 19489924 · Received June 7, 2024

    Report

    Report Number
    3027605735-2024-00029
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 15, 2024
    Report Date
    August 27, 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 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.

    Additional Manufacturer Narrative · 0

    3 PEN NEEDLES IMPACTED FROM LOT # 2062289. SEE MEDWATCH COMPLETED SECTION C FORM ATTACHED.

    Description of Event or Problem · 0

    CUSTOMERS REPORTED THAT THE MICRO-FINE NEEDLES ARE CLOGGED. THERE WAS NO CLOGGING PROBLEM BEFORE, BUT THIS YEAR THERE ARE MORE CLOGGING NEEDLES. THE PRODUCTION DATES ARE 2021 AND 2022. SOMETIMES NEEDLES IN ONE BOX ARE ALL GOOD, AND SOMETIMES THERE ARE SEVERAL CLOGGING ONES IN ONE BOX. THE INJECTION PEN HAS BEEN REPLACED TO ELIMINATE THE PROBLEM WITH THE INJECTION PEN. THE NEEDLES WERE PURCHASED AT A LOCAL PHARMACIES BUT COULDN¿T REMEMBER THE DATE OF PURCHASE. THE PROBLEM OF ONE NEEDLE CLOGGING OCCURRED AGAIN DURING THE EXHAUST BEFORE USE ON MAY 15TH. THERE WERE THREE NEEDLES IN THE BOX THAT WERE CLOGGED, BUT THEY WERE ALL DISCARDED. THERE WAS NO DIFFERENCE IN APPEARANCE AND NO PHOTOS WERE TAKEN. PRODUCT NUMBER 329487, BATCH NUMBER 2062289, REGISTRATION NUMBER: NATIONAL MEDICAL DEVICE REGISTRATION CERTIFICATE (B)(4) . CUSTOMER PURCHASED MULTIPLE BOXES OF 7CT 31G*5MM NEEDLES AT ONE TIME, BUT ONLY ONE BOX LEFT IN HAND, AND CUSTOMER IS NOT SURE WHETHER THE NEEDLES CLOGGED CAME FROM THAT BOX. NO COMPLAINT RESPONSE IS REQUIRED. SAMPLE AVAILABILITY: NO SAMPLE AVAILABILITY DETAILS: NO SAMPLE AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864975 PEN NEEDLE 31GX5MM 7 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329487 2062289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown