BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y18GAX1.16IN PRN/EC SLM

    MDR report key: 9616339 · Received January 22, 2020

    Report

    Report Number
    3006948883-2020-00020
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 24, 2020
    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 IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8080269. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y18GAX1.16IN PRN/EC SLM EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO HOSPITAL FOR FRACTURING OF RIGHT TIBIOFIBULA AND INTRAMEDULLARY NAIL FIXATION FOR FRACTURING OF RIGHT TIBIA WAS PERFORMED. INDWELLING NEEDLE WAS LEAKAGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II Y18GAX1.16IN PRN/EC SLM EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO HOSPITAL FOR FRACTURING OF RIGHT TIBIOFIBULA AND INTRAMEDULLARY NAIL FIXATION FOR FRACTURING OF RIGHT TIBIA WAS PERFORMED. INDWELLING NEEDLE WAS LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82511 INTIMA-II Y18GAX1.16IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8080269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other