BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8051694 · Received November 8, 2018

    Report

    Report Number
    1911916-2018-00617
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    September 17, 2018
    Report Date
    December 10, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051244
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED FOR EVALUATION. THE DEFECT APPEARS TO BE EPOXY, THEREFORE FAILURE MODE IS VERIFIED. FROM THE COLOR AND POSITION THE PROBABLE CAUSE WAS EPOXY ON THE CATERPILLAR BELTS. THIS OCCURS IF A MISASSEMBLED NEEDLE, WITH EPOXY, COMES IN CONTACT WITH THE CATERPILLAR BELTS. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME AS THE DEFECT RATE IS WITHIN ALLOWED QUALITY LIMITS PER BD¿S SPECIFICATIONS. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. ASSEMBLY BATCH 6153707 HAD 11 VISUAL INSPECTIONS PERFORMED ON 700 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED TWICE PER PROCEDURE DURING THE ASSEMBLY OF THIS BATCH. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE NEEDLE THAT THE NEEDLE IS DIRTY. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THAT THE NEEDLE IS DIRTY. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893258 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6152940 30382903051244

    Patients

    Seq Age Sex Outcome Treatment
    1 Other