BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 8805410 · Received July 18, 2019

    Report

    Report Number
    3006948883-2019-00575
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 12, 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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8262052. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6)2019 , PATIENTS WERE TREATED WITH BRONCHIAL PNEUMONIA INFUSION VIA CATHETER, NOTICED BLOOD RETURN, FLOW OCCULED AFTER COMPLETED PENETRATION. NURSE RETRACT THE CATHETER AT ONCE AND NOTICED KINK MARK ON CATHETER NO HARM/ADVERSE REACTIONS NOTICED ON PATIENTS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, PATIENTS WERE TREATED WITH BRONCHIAL PNEUMONIA INFUSION VIA CATHETER, NOTICED BLOOD RETURN, FLOW OCCURRED AFTER COMPLETED PENETRATION. NURSE RETRACT THE CATHETER AT ONCE AND NOTICED KINK MARK ON CATHETER. NO HARM/ADVERSE REACTIONS NOTICED ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599505 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8262052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other