BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 7 PACK

    MDR report key: 19480343 · Received June 6, 2024

    Report

    Report Number
    3027605735-2024-00030
    Event Type
    Malfunction
    Date Received
    June 6, 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

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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

    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
    1851039 PEN NEEDLE 31GX5MM 7 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329487 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown