BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 30G X 1/2

    MDR report key: 10175512 · Received June 19, 2020

    Report

    Report Number
    1911916-2020-00569
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 5, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. IT COULD BE POSSIBLE THAT WHILE INTRODUCING THE NEEDLE THROUGH THE STOPPER VIAL THE NEEDLE GOT CLOGGED. ALL THE PRODUCTS ARE 100% INSPECTED WITH A VISION SYSTEM FOR CLOGGED NEEDLE DURING THE MANUFACTURING PROCESS. 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. 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 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 57TH COMPLAINT FOR ABOVE LISTED LOT # 9162858 FOR NEEDLE CLOGGED. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CONCLUSION AND BY NOT HAVING A SAMPLE FOR ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. AT THIS TIME NO ADDITIONAL ACTIONS WILL BE TAKEN REGARDING THIS COMPLAINT. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES 30G X 1/2 EXPERIENCED CLOGGED/BLOCKED NEEDLES. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE USER FACILITY WAS USING INJECTION NEEDLES, THE TWO INJECTION NEEDLES SAMPLED CANNOT BE VENTED BEFORE INJECTION, WHICH CAUSED THE INJECTION PROCESS TO FAIL TO PROCEED NORMALLY; THE TEST SHOWED THAT THE NEEDLE WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636287 BD PRECISIONGLIDE NEEDLE 30G X 1/2 HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 8324761 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other