BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12194030 · Received July 19, 2021

    Report

    Report Number
    3006948883-2021-00810
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 13, 2021
    Report Date
    July 1, 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 BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050046. 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. INVESTIGATION CONCLUSION: THE COMPLAINT GAUGE IS 24G,ASSEMBLY AT AUTO LINE 2 IN (B)(6) 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 ABNORMALITY FOR IT. REVIEW OF THE PRODUCTION RECORDS AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT WERE PERFORMED, AND NO ABNORMALITY, DEVIATION OR REWORK WERE FOUND. IN THE ASSEMBLY PROCESS OF PRN, THERE IS TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE LUER CONNECTOR SEAT TO A CERTAIN DEPTH AND THE ASSEMBLY THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE DEVICE ALARMS AND REMOVES THE PRODUCT. HOWEVER, ALTHOUGH PRN IS FASTENED TO THE PRODUCT DURING ASSEMBLY, PRN MAY COME LOOSE IF IT IS SHAKEN DURING TRANSPORTATION. THEREFORE, THE OPERATING PROCEDURE IN THE PRODUCT MANUAL SUGGESTS THAT THE PRN SHOULD BE TIGHTENED BEFORE USE TO PREVENT LEAKAGE. 2 PCS RETAINED SAMPLES WERE TAKEN FOR PRN THREAD INSPECTION. NO ABNORMALITY OBSERVED. PRN TORQUE AND LEAKAGE POTENTIAL WERE TESTED, AND THE RESULTS MET PRODUCT SPECIFICATIONS. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. NO SAMPLE AND PICTURE WERE RETURNED AND NO ABNORMAL FOUND ON PROCESS, THE ROOT CAUSE OF LEAKAGE AT THE PRN OF THE INDWELLING NEEDLE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES FOUND LEAKAGE OF HEPARIN CAP WHEN REHYDRATING 7 BEDS OF PATIENTS WITH INDWELLING INTRAVENOUS NEEDLES. THEY IMMEDIATELY REPLACED THE HEPARIN CAP AND REHYDRATED THE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088312 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 1050046

    Patients

    Seq Age Sex Outcome Treatment
    1