BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 9616517 · Received January 22, 2020

    Report

    Report Number
    1911916-2020-00024
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 6, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. ONE SAMPLE CAME WITH NO PACKAGING BLISTER, IT HAS THE PLASTIC SHIELD. IT HAS WHITE EPOXY TOWARDS THE MIDDLE OF THE NEEDLE. IT IS ABOUT 3/8¿ LONG. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR. THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. IN THIS CASE IT MAY HAVE HAPPENED THAT A JAM OCCURRED, AND THE EQUIPMENT DISPENSED SILICONE BEFORE THE PART WAS MOVED TO THE NEXT STATION AND IT WAS NOT DETECTED IN THE NEXT PROCESSES. 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 WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR THE LOT # 9193579 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. IN THIS CASE IT MAY HAVE HAPPENED THAT A JAM OCCURRED, AND THE EQUIPMENT DISPENSED SILICONE BEFORE THE PART WAS MOVED TO THE NEXT STATION AND IT WAS NOT DETECTED IN THE NEXT PROCESSES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE HAD EPOXY ON THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305195 BATCH NO.: 9193579. IT WAS REPORTED THAT THE NEEDLE HAS A WHITE SUBSTANCE ON IT THAT APPEARS TO BE DRIED GLUE. PER EMAIL/VOICEMAIL: CUSTOMER CALLED TO REPORT THAT A BD NEEDLE HAD WHITE SUBSTANCE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82563 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305195 9193579 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 Other