BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15089773 · Received July 22, 2022

    Report

    Report Number
    3014704491-2022-00292
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    May 30, 2022
    Report Date
    July 22, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1320169. 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. DHR REVIEW RESULTS: THE COMPLAINT GAUGE IS 24G, ASSEMBLY AT AUTO LINE 2 IN DEC. 2021, PACKAGING AT CFS PACKING MACHINE IN DEC. 2021, LOT QUANTITY IS (B)(4). REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORTS FOR THIS LOT PRODUCTS, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOR IT. REVIEW THE PRODUCTION RECORDS AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCTS, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITY. REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITY IS OBSERVED. (THE CATHETER FOR PRODUCTION OF THIS LOT IS PANEL MATERIAL, MATERIAL NUMBER: B5171AAAL, BATCH NUMBER:1147408/1243174/1119669/1148408/1119668).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER BROKE ON THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS FOUND THAT THE TUBE OF THE CLOSED VEIN INDWELLING NEEDLE WAS BROKEN AND COULD NOT BE PLACED NORMALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560980 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1320169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown