BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML ULTRA FINE INSULIN SYRINGE

    MDR report key: 10019324 · Received May 1, 2020

    Report

    Report Number
    1920898-2020-00455
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 20, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294108
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 8241181 WAS REPORTED, HOWEVER, THAT IS NOT A MANUFACTURED LOT# FOR THIS PRODUCT LINE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR LABEL INFORMATION MISSING (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. NO SAMPLES 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. UNABLE TO PERFORM DHR CHECK FOR LABEL INFORMATION MISSING (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. AS NO SAMPLES AND/OR PHOTO(S) WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX LABEL INFORMATION IS MISSING WITH A BD 1ML ULTRA FINE¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE OR COPYRIGHT DATE ON ANY OF THE BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480170 BD 1ML ULTRA FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329410 SEE H.10 30382903294108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other