BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8411915 · Received March 12, 2019

    Report

    Report Number
    1911916-2019-00256
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR THE LOT# 8173882 FOR THE SAME DEFECTS OR SYMPTOMS. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8173882 DURING THIS PRODUCTION RUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THE METAL NEEDLE BROKE OFF AT THE WHITE TIP AREA OF THE HUB WHILE INSERTING THE NEEDLE INTO THE AMPULE. VERBATIM: METAL NEEDLE BROKE OFF AT WHITE TIP AREA OF HUB WHILE INSERTING NEEDLE INTO AMPULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208142 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173882 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other