BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 8336503 · Received February 13, 2019

    Report

    Report Number
    9616657-2019-00124
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    February 19, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: REASON CODE FOR NO EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE DID NOT WORK DURING INJECTION; THE INSULIN DOES NOT COME THROUGH THE NEEDLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE ON LOT # 8072795. 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 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE DID NOT WORK DURING INJECTION; THE INSULIN DOES NOT COME THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131222 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8072795 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other