BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10174825 · Received June 19, 2020

    Report

    Report Number
    1911916-2020-00565
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    April 30, 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: THE CUSTOMER PROVIDED THREE PHOTOS FOR INVESTIGATION. THE THREE PHOTOS SHOW A HOOK AT THE NEEDLE TIP. IT SEEMS THE DAMAGED NEEDLE TIP COULD HAVE BEEN INDUCED WHILE UNCAPPING-CAPPING THE NEEDLE ASSEMBLY FROM THE PHOTOS PROVIDED. THIS 30- GAUGE NEEDLE IS VERY SENSITIVE TO HANDLE. IT CAN EASILY DAMAGE THE NEEDLE TIP WHEN THE RIGHT METHOD IS NOT FOLLOWED. AS PART OF THE MANUFACTURING PROCESS, AN AUTOMATED MECHANISM CHECKS 100% OF ALL THE PRODUCTS FOR DAMAGED NEEDLE TIP. ALSO, ANOTHER AUTOMATED VISION SYSTEM CHECKS ALL THE PARTS FOR A CLOGGED NEEDLE. ON JUNE 04, 2020, AWARENESS MEETING WITH THE BD CHINA TEAM HELD TO EXPLAIN HOW SENSITIVE IT IS TO HANDLE THIS NEEDLE PRODUCT AND EASILY DAMAGE THE NEEDLE TIP. THE BD (B)(6) TEAM WILL MEET WITH THE CUSTOMER TO PROVIDE GUIDANCE/ TRAINING. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR ABOVE LISTED LOT # 9162858 FOR THIS DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. ROOT CAUSE DESCRIPTION: BASED ON THE PHOTOS PROVIDED, THE DAMAGED NEEDLE TIP COULD HAVE BEEN INDUCED WHEN HANDLING THE NEEDLES. WITH REGARD TO THE CLOGGED NEEDLE, THE HYPOTHESIS IS THAT POSSIBLY THE EPOXY MAY HAVE CAUSED THE CLOGGED. TWO SAMPLES FROM LOT# 9077689 WERE RECEIVED AND SENT TO A SPECIALIZED LABORATORY FOR ANALYSIS CONFIRMING THE SYMPTOM. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 11 BD PRECISIONGLIDE¿ NEEDLES WERE FOUND BLOCKED BEFORE USE WHILE BEING TESTED FOR BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THEIR COMPANY SAMPLED 1250 NEEDLES RANDOMLY FROM BATCH 9162858 NEEDLES IN THE WAREHOUSE FOR NEEDLE BLOCKAGE AND NEEDLE TIP QUALITY TEST ON (B)(6) 2020. TEST SEQUENCE: FIRSTLY, THE QUALITY OF THE NEEDLE TIP WAS TESTED. TEST METHOD: THE NEEDLE TIP WAS USED TO SCRAPE THE COTTON FIBER, AND THE NEEDLE SAMPLE THAT COULD HANG THE COTTON FIBER WAS THEN OBSERVED BY MICROSCOPE. AFTER THE QUALITY DETECTION OF THE NEEDLE TIP, THE NEEDLE BLOCKAGE WAS DETECTED BY CONNECTING THE NEEDLE TO THE SYRINGE FILLED WITH PURIFIED WATER FOR DRAINAGE, AND IF THE PURIFIED WATER COULD NOT PASS THROUGH, THE NEEDLE BLOCKAGE WAS DETECTED. A TOTAL OF 26 NEEDLE TIPS WERE FOUND TO BE DEFECTIVE IN THE 1250 RANDOMLY SELECTED SAMPLES. AMONG THEM, 1 NEEDLE TIP BARB LENGTH WERE LONGER THAN 40 M AND ANOTHER 11 NEEDLES WERE BLOCKED AND COULD NOT DRAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636257 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9162858 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other