BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13095161 · Received December 28, 2021

    Report

    Report Number
    3014704491-2021-00395
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 8, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 1203278. 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. DHR REVIEW(LOT# 1203278: THE COMPLAINT GAUGE IS 24G, ASSEMBLY AT AUTO LINE 2 IN AUG. 2021,PACKAGING AT CFS PACKING MACHINE IN AUG. 2021, LOT QUANTITY IS 186K. REVIEWED THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMALITY FOR IT FOUND. REVIEWED THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, AND NO ABNORMALITY, DEVIATION OR REWORK ACTIVITY FOUND. CHECKED INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITY WAS OBSERVED. (THE CATHETER FOR PRODUCTION OF THIS BATCH IS PANEL MATERIAL, MATERIAL NUMBER: B5171AAAL, BATCH NUMBER: 1055527/1055528/1055529). REVIEWED THE OUT GOING INSPECTION RECORD, THE PRN TORQUE MET THE OUT GOING INSPECT REQUIREMENT. THE PRN LOT NUMBER FOR THIS PRODUCT IS LOT#1176120/1176141, REVIEWED THE INCOMING INSPECTION RESULT, NO ABNORMALITY FOUND. THERE IS TORQUE FORCE TEST MONITORING FOR PRN CAP MACHINES IN THE FACTORY'S INTERNAL MANUFACTURING PROCESS. DEFECTIVE PRODUCTS IN PRN TORQUE TEST WILL BE REMOVED BY ALARM. THUS, THE TORQUE OF THE PRODUCT AFTER PRN ASSEMBLY SHOULD BE IN ACCORDANCE WITH THE PROCESS. 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. TWO RETAINED SAMPLES OF THIS BATCH ARE TAKEN TO TEST THE PRN REMOVAL TORQUE AND THE CATHETER PULL FORCE, AND THE TEST RESULTS MEET THE PRODUCT REQUIREMENTS. NO SIMILAR COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. NO ABNORMALITY FOUND ON PROCESS, AS NO DEFECT SAMPLE RETURNED, AND THE PROCESS OF USING THE PRODUCT IS UNKNOWN. THE ROOT CAUSE OF PRN MISSING AND CATHETER DISCONNECTION CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A MISSING PRN, AND A SEPARATION OF THE CATHETER FROM THE HUB. THE DEVICE MALFUNCTION RESULTED IN THE PATIENT RECEIVING MEDICAL INTERVENTION WITH A "CT, B ULTRASOUND AND FILM," PERFORMED. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PRN WAS FOUND MISSING DURING INTRAVENOUS INFUSION, AND THE FAMILY OF THE CHILD WAS INFORMED TO REMOVE THE INDWELLING NEEDLE. AFTER REMOVING THE INDWELLING NEEDLE, IT WAS FOUND THAT THE CATHETER TUBING WAS DISCONNECTED AND THE STUMP WAS MISSING. THE DIRECTOR TOOK THE CHILDREN FOR CT, B ULTRASOUND AND FILM, AND NO STUMP WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991401 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1203278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention