BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12832101 · Received November 17, 2021

    Report

    Report Number
    3014704491-2021-00270
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. 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. INVESTIGATION CONCLUSION: DHR REVIEW(LOT# 1020006): THE COMPLAINT GAUGE IS 22G,ASSEMBLY AT AUTO LINE 3 IN FEB. 2021,PACKAGING AT R240 PACKING MACHINE IN FEB. 2021, LOT QUANTITY IS (B)(4). REVIEWED THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMALITY FOUND. REVIEWED THE PRODUCTION RECORDS AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES FOUND. LEAKAGE TEST PERFORMED ONTHE 2 RETAINED SAMPLES, ALL PASSED, NO LEAKAGE. NO ABNORMALITY FOUND ON PROCESS, AS NO DEFECTIVE SAMPLE RETURNED, FURTHER ANALYSIS CANNOT BE DONE. THE ROOT CAUSE OF LEAKAGE AT THE JOINT OF THE INDWELLING NEEDLE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS LEAKAGE AT THE JOINT OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730631 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown