BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 9186897 · Received October 14, 2019

    Report

    Report Number
    3006948883-2019-00859
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 27, 2019
    Report Date
    November 21, 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

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023812. 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. DURING EVALUATION OF THE SUBMITTED DEVICE, OUR QUALITY ENGINEERS IDENTIFIED A SMALL WOUND ON THE CATHETER TUBING THAT HAD LEAD TO THE LEAK EXPERIENCED. IN RESPONSE A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED, BUT WAS UNABLE TO IDENTIFY ANY POTENTIAL SOURCES FOR THE OBSERVED DAMAGE. UNFORTUNATELY BASED ON OUR REVIEW, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II 24GAX0.75IN PRN SLM NPVC EXPERIENCED LEAKAGE AT CATHETER AND HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, CUSTOMER FOUND THAT THE LEAKAGE AT THE JUNCTION BETWEEN THE CATHETER HUB AND THE CATHETER.

    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 24GAX0.75IN PRN SLM NPVC EXPERIENCED LEAKAGE AT CATHETER AND HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, CUSTOMER FOUND THAT THE LEAKAGE AT THE JUNCTION BETWEEN THE CATHETER HUB AND THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983497 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023812

    Patients

    Seq Age Sex Outcome Treatment
    1 Other