BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12619212 · Received October 12, 2021

    Report

    Report Number
    3014704491-2021-00193
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 22, 2021
    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 · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020967. 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. INVESTIGATION CONCLUSION: DHR REVIEW: THE COMPLAINT GAUGE IS 24G,ASSEMBLY AT AUTO LINE 4 IN FEB. 2021,PACKAGING AT CFS PACKING MACHINE 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. REVIEWED THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES FOUND. LEAKAGE TEST THE 2 RETAINED SAMPLES, ALL PASSED. NO ABNORMALITY FOUND ON PROCESS, AS NO DEFECTIVE SAMPLE RETURNED, FURTHER ANALYSIS COULD NOT BE DONE. THE ROOT CAUSE OF THE LEAKAGE BETWEEN THE NEEDLE STEM AND THE FRONT-END HOSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INDWELLING NEEDLE PUNCTURE FOR THE PATIENT, FLUID LEAKAGE WAS FOUND AT THE CONNECTION BETWEEN THE NEEDLE STEM AND THE FRONT-END HOSE. THE PUNCTURE WAS STOPPED IMMEDIATELY, THE NEEDLE WAS PULLED OUT, AND THE INDWELLING NEEDLE WAS REPLACED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513985 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ 1020967

    Patients

    Seq Age Sex Outcome Treatment
    1