BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8287018 · Received January 29, 2019

    Report

    Report Number
    3006948883-2019-00110
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 14, 2019
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 BATCH OF INTIMA II . 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. ADDITIONALLY, DURING OUR VISUAL EVALUATION OF THE RETURNED DEVICE, IT WAS DETERMINED THAT THE LEAK ORIGINATED FROM THE A HOLE IN THE MOLDING OF THE PADDLE HUB. A SUBSEQUENT REVIEW OF OUR MAINTENANCE RECORDS FOUND THAT A KEY COMPONENT IN OUR MANUFACTURING MACHINERY HAD BEEN REPLACED AFTER THE COMPLETION OF THIS BATCH OF PRODUCT. IN ADDITION TO THIS REPAIR, OUR MANUFACTURING FACILITY HAS RETRAINED THE MANUFACTURING AND INSPECTION PERSONNEL TO BETTER IDENTIFY AND SEGREGATE THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE D SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE DURING USE.

    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 D SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79051 D SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 8080269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other