BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9364667 · Received November 22, 2019

    Report

    Report Number
    3006948883-2019-00966
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 19, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050895. 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. UNFORTUNATELY 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 HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING LEAKAGE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: (B)(6) 2019, WHEN THE NURSE USED THE INDWELLING NEEDLE INFUSION FOR THE PATIENT, SHE FOUND THE YELLOW INDWELLING NEEDLE BIFURCATED IN THE CONNECTION OF THE THIN TUBE TO LEAK LIQUID DURING THE EXHAUST, AND IMMEDIATELY CHANGED 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 HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING LEAKAGE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: (B)(6) 2019, WHEN THE NURSE USED THE INDWELLING NEEDLE INFUSION FOR THE PATIENT, SHE FOUND THE YELLOW INDWELLING NEEDLE BIFURCATED IN THE CONNECTION OF THE THIN TUBE TO LEAK LIQUID DURING THE EXHAUST, AND IMMEDIATELY CHANGED THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160800 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other