BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM BD ULTRA FINE¿ III PEN NEEDLE

    MDR report key: 7261114 · Received February 9, 2018

    Report

    Report Number
    9616656-2018-00013
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 12, 2018
    Report Date
    March 1, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403830013
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION SUMMARY: CUSTOMER RETURNED (20) OPENED/ UNSEALED BD PEN NEEDLES AND 12 LOSE TEAR DROP LABELS; 13 OF THE NEEDLES WERE 4MM, 32G AND 7 WERE 8MM, 31G. CONSUMER REPORTED MIXED PRODUCT, STATED THAT THERE ARE TWO SIZES OF NEEDLES IN HER BOX OF 8MM PEN NEEDLES. ALL RETURNED PEN NEEDLES WERE EXAMINED. THERE WERE 13 NANOS (4MM, 32G) WITHOUT THE TEAR DROP LABEL. ALSO RECEIVED FOR INVESTIGATION, HERE WERE 7 8MM, 31G NEEDLES WITHOUT THE TEAR DROP LABEL ATTACHED AND THERE WERE 8 LOSE TEARDROP LABELS (ALL 8 TEAR DROP LABELS WERE FOR 8MM, 31G - LOT # 7151839). BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS INVESTIGATION AND SINCE ALL RETURNED SAMPLES WERE ALREADY OPENED, THE ALLEGED DEFECT (MIXED PRODUCT) COULD NOT BE CONFIRMED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7151839. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THERE WAS MIXED PRODUCT RECEIVED IN A BOX OF 8MM BD ULTRA FINE¿ III PEN NEEDLES. SOME OF THE PEN NEEDLES WERE REPORTED TO BE LONGER THAN THE INTENDED 8MM LENGTH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103067 8MM BD ULTRA FINE¿ III PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7151839 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other