BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15089300 · Received July 22, 2022

    Report

    Report Number
    3014704491-2022-00290
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 13, 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: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053255. 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(LOT#2053255): THE COMPLAINT GAUGE IS 24G, ASSEMBLY AT AUTO LINE 2 IN MAR. 2022,PACKAGING AT R240 PACKING MACHINE IN MAR. 2022, 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. NO DEFECT SAMPLES AND PICTURES WERE RETURNED FROM CUSTOMER, AND THE LEAKAGE SITE AND DAMAGE STATE OF THE INDWELLING NEEDLE CANNOT BE DETERMINED. LEAKAGE TEST THE RETAINED SAMPLE OF THIS LOT, NO LEAKAGE IS FOUND. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE. AS NO DEFECTIVE SAMPLE RETURNED, FURTHER ANALYSIS CANNOT BE DONE, AND THE ROOT CAUSE OF THE COMPLAINED DEFECT 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: DURING THE INFUSION PROCESS, THE PATIENT WAS FOUND TO HAVE FLUID LEAKAGE FROM THE INDWELLING NEEDLE AFTER CONNECTING WITH THE INFUSION SET, AND THE LEAKAGE WAS FOUND FROM THE END OF THE INDWELLING NEEDLE, SO THE INDWELLING NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608110 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2053255

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown