BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II

    MDR report key: 8855750 · Received August 2, 2019

    Report

    Report Number
    3006948883-2019-00623
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    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 7075286. 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 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT LEAKAGE AT PRN DURING PRIMING.

    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 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT LEAKAGE AT PRN DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648015 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7075286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other