BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10176049 · Received June 19, 2020

    Report

    Report Number
    1911916-2020-00572
    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 FOUR PHOTOS FOR INVESTIGATION. 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 CAUSE THE CLOGGED. TWO SAMPLES FROM LOT# 9077689 WERE RECEIVED AND SENT TO A SPECIALIZED LABORATORY FOR ANALYSIS CONFIRMING THE SYMPTOM. ADDITIONALLY, 2000 UNUSED PARTS OF THE LOT# 8324761 WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED FOR DAMAGES AND CLOGGING. NO DAMAGED TIP OBSERVED ON ANY OF THE SAMPLES. TWO SAMPLES FOUND PARTIALLY CLOGGED. THEY WERE ALSO SENT TO THE SPECIALIZED LABORATORY CONFIRMING THE SYMPTOM. ON (B)(6) 2020, AWARENESS MEETING WITH THE BD CHINA TEAM HELD TO EXPLAIN HOW SENSITIVE 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WOULD 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 THE IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 56TH COMPLAINT FOR ABOVE LISTED LOT # 9162858 FOR NEEDLE CLOGGED. PREVIOUS COMPLAINT , 1612665,1577044,1565569,1565417,1563458,1537858,1533700,1531451,1526365,1522948,1515569,1514153,1514144,1506337,1506331,1506323,1506319, 1498428, 1490329, 1488235, 1484206, 1488121, 1389598, 1387407, 1379571, 1379556, 1379341, 368033,1368018, 1368015, 1349090, 1337973, 1324614, 1323823, 1318531, 1259942, 1242031, 1239573, 1198795, 1186599, 1170580, 1159606, 1133137, 1131785, 1129592, 1114017, 1105806, 1098015, 1087908, 1069299, 1067242, 1007882, 1000465, 969946, 955528, 901446. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE WAS BLOCKED WITH A BD PRECISIONGLIDE¿ NEEDLE. THIS OCCURRED ON 85 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THEIR COMPANY SAMPLED 1250 NEEDLES RANDOMLY FROM BATCH 8324761 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 34 NEEDLE TIPS WERE FOUND TO BE DEFECTIVE IN THE 1250 RANDOMLY SELECTED SAMPLES. FIFTY-ONE NEEDLES WERE FOUND TO BE BLOCKED AND UNABLE TO DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636298 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 8324761 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other