BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8956679 · Received September 3, 2019

    Report

    Report Number
    3006948883-2019-00720
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 7, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8043036. 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. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON THE CAP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, A HOSPITALIZED PATIENT WITH HEART FAILURE DUE TO RENAL FAILURE, WAS ADMITTED TO HOSPITAL. AT 8.7.8. HE WAS TREATED WITH VENOUS INDWELLING NEEDLE PUNCTURE AND CLOSED VENOUS INDWELLING NEEDLE (XIANGMA). BEFORE OPERATION, IT WAS FOUND THERE HAS HAIR ON THE HEPARIN CAP. SO DISCARDED THE INDWELLING NEEDLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON THE CAP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, A HOSPITALIZED PATIENT WITH HEART FAILURE DUE TO RENAL FAILURE, WAS ADMITTED TO HOSPITAL. AT 8.7.8. HE WAS TREATED WITH VENOUS INDWELLING NEEDLE PUNCTURE AND CLOSED VENOUS INDWELLING NEEDLE (XIANGMA). BEFORE OPERATION, IT WAS FOUND THERE HAS HAIR ON THE HEPARIN CAP. SO DISCARDED THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750634 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 8043036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other