BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT

    MDR report key: 8412675 · Received March 12, 2019

    Report

    Report Number
    9616656-2019-00229
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 20, 2019
    Report Date
    February 26, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT FOR NEEDLE CLOG (DURING PRIME) ON LOT # 8072768. 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 90 CT HAD NO INSULIN FLOW WHEN PRIMING. THE FOLLOWING WAS REPORTED, "CONSUMER REPORTED DURING PRIMING, NO INSULIN FLOW. DOES NOT ALWAYS PRIME BEFORE USE. STATED IT HAPPENED WITH 6 PEN NEEDLES. DISCARDED SAMPLES. LOT: 8072768, ITEM: 320883, EXPIRATION DATE: 2023-03-31. INCIDENT DATE UNKNOWN. CONSUMER CALLING BACK WITH ADDRESS TO SEND REPLACEMENTS TO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205349 PEN NDL 32G 4MM 90 CT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8072768 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other