BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31 X 5MM XTW 100 CT

    MDR report key: 21014488 · Received December 24, 2024

    Report

    Report Number
    3023359743-2024-00784
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Report Date
    March 6, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11. CORRECTION MADE TO H6 (INVESTIGATION TYPE, INVESTIGATION FINDING, INVESTIGATION CONCLUSION). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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 UNABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO ISSUES WERE OBSERVED WITH THE RETURNED PHOTOS THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CAN YOU PLEASE VERIFY THIS CUSTOMER'S COMPLAINT? - THIS IS TO CLAIM THE ARRIVAL OF SOME PIECES OF THE REFERENCE BD MICROFINE AGO G31 5MM 100PZ MINSAN 981154317 WITHOUT SILICONE SUPPORT AND AT THE SAME TIME OF HOSPITAL DIE. THIS IS A QUANTITY OF 115 PCS; ESPECIALLY, 86 PCS LOT 2263457 EXPIRY 09/2027, 29 PCS LOT 2257067 EXPIRY 09/2027. ATTACHED ARE THE REFERENCE AND ARRIVAL DDTS OF THE PRODUCT IN QUESTION. 03 DECEMBER 2024 V. COYNE ADDITIONAL INFORMATION - SEE ATTACHMENTS. SEEMS THAT THIS CUSTOMER RECEIVED 115 PCS / UNITS OF BD MICROFINE AGO G31 5MM WITHOUT THE SILICONE PROTECTION THAT EVERY NEEDLE SHOULD HAVE. AND THE BOX ITSELF DIDN'T HAVE A SPECIAL BARCODE, IF YOU SEARCH ON GOOGLE "FUSTELLA OSPEDALIERS" WILL SHOW YOU THAT IT'S LIKE A SMALL ADHESIVE PATCH WITH SOME BARCODES AND NAMES. THIS ADHESIVE PATCH SHOULD BE ON THE BACK OF THE BOX AND ITS MISSING LIKE IN THE PHOTO BELLOW THAT CUSTOMER SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90988 PEN NEEDLE 31 X 5MM XTW 100 CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 000000000000324840 2257067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown