BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8170135 · Received December 17, 2018

    Report

    Report Number
    9616657-2018-00071
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    December 1, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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 · 0

    IT WAS REPORTED THAT BD ULTRA FINE PEN NEEDLES WERE NOT HOLLOWED OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8072793, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-05-15. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE NOT HOLLOWED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009764 BD ULTRA FINE¿ PEN NEEDLES AUTOINJECTOR NEEDLE FMI BECTON, DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other