BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12064294 · Received June 24, 2021

    Report

    Report Number
    3006948883-2021-00706
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW. INVESTIGATION CONCLUSION: THE COMPLAINT GAUGE IS 22G,ASSEMBLY AT AUTO LINE 3 IN FEB. 2021, LOT QUANTITY IS 186K. REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOR IT. REVIEW THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES. COMPLAINT DEFORMATION DESCRIPTION: WHEN THE NEEDLE WAS WITHDRAWN AFTER PUNCTURE, A SMALL AMOUNT OF BLOOD WITH THE NEEDLE OOZE TO THE NEEDLE HANDLE. NO ACTUAL SAMPLE AND PICTURE WAS RETURNED, THE DEFECT STATUS COULD NOT BE CONFIRMED. 2 SAMPLES WERE RETAINED FOR 800MM AND 45 PSI LEAKAGE TEST, WHICH PASSED THE TEST, AT THE SAME TIME, OBSERVE THE SEALABLE SEPTUM WITHOUT ABNORMALITY. NO SAMPLE WAS RECEIVED FROM THE REPORTED LOT #. CONCLUSION(S): NO ABNORMALITY FOUND ON PROCESS, AS NO DEFECTIVE SAMPLE RETURNED, AND THE USE STATUS OF NURSES WAS UNKNOWN. THE ROOT CAUSE OF A SMALL AMOUNT OF BLOOD LEAKING ALONG WITH THE NEEDLE TO THE NEEDLE HANDLE AT THE TIME OF WITHDRAWAL CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, WHEN USING THE CLOSED VEIN INDWELING NEEDLE PRODUCED BY SUZHOU BD MEDICAL INSTRUMENT CO., LTD., A SMALL AMOUNT OF BLOOD EXUDATED TO THE NEEDLE HANDLE AFTER PUNCTURE, AND THE INDWELING NEEDLE WAS REPLACED AND THE NEEDLE WAS RE-PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960023 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1