BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 9910178 · Received April 1, 2020

    Report

    Report Number
    3006948883-2020-00108
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    June 29, 2019
    Report Date
    April 6, 2020
    Manufacturer
    BD (SUZHOU)
    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: IN RESPONSE TO THE EVENT REPORTED BY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8241456. 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 H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER BROKE AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 2019.6.29, THE PATIENT UNDERWENT CT ENHANCED SCAN. DURING THE SALINE TEST, THE CATHETER BROKE AND THE LIQUID WAS EXPOSED.

    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 WAS REPORTED THAT INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER BROKE AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT UNDERWENT CT ENHANCED SCAN. DURING THE SALINE TEST, THE CATHETER BROKE AND THE LIQUID WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372865 INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 8241456

    Patients

    Seq Age Sex Outcome Treatment
    1 Other