BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31G X 5/16"

    MDR report key: 7003083 · Received November 6, 2017

    Report

    Report Number
    1920898-2017-00302
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 16, 2017
    Report Date
    March 29, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SEVERITY: S2; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE RELATED 1ST COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7023640. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CATALOG / BATCH NUMBER MISMATCH IN THE DATABASE. DHR CANNOT BE COMPLETED. 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. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31G X 5/16" THE SYRINGE NEEDLE BROKE OFF INTO CONSUMER¿S ARM AFTER INJECTION. CONSUMER'S SPOUSE REMOVED THE NEEDLE WITH TWEEZERS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784322 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31G X 5/16" INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023640 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other