BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8283940 · Received January 28, 2019

    Report

    Report Number
    3006948883-2019-00109
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 21, 2019
    Report Date
    March 12, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233349. OUR RECORDS SHOW THAT THIS IS THE THIRD INSTANCE OF LEAKAGE 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 CONFIRM THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CRACK AT THE SEPTUM AND TUBING CONNECTION OF A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, RESULTED IN 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 THERE WAS A CRACK AT THE SEPTUM AND TUBING CONNECTION OF A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, RESULTED IN LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73589 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other