BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13337070 · Received January 24, 2022

    Report

    Report Number
    3014704491-2022-00031
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    November 15, 2021
    Report Date
    February 6, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. 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

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050039. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD THE CATHETER KINK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE PROCESS OF VENIPUNCTURE, THE DISCONTINUOUS PART OF THE INDWELLING NEEDLE WAS FOUND TO BE TWISTED, SO IT WAS REPLACED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD THE CATHETER KINK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE PROCESS OF VENIPUNCTURE, THE DISCONTINUOUS PART OF THE INDWELLING NEEDLE WAS FOUND TO BE TWISTED, SO IT WAS REPLACED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687741 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown