BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7137164 · Received December 21, 2017

    Report

    Report Number
    9616656-2017-00163
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 27, 2017
    Report Date
    March 13, 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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SEVERITY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7101669. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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 A BD ULTRA FINE¿ INSULIN PEN NEEDLE ARRIVED WITHOUT THE TEAR DROP LABEL. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917005 BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7101669 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other