BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8560356 · Received April 29, 2019

    Report

    Report Number
    3006948883-2019-00312
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 10, 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 8043022. OUR RECORDS SHOW THAT THIS IS THE SECOND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THE FLOW RATE WAS SLOW AFTER WITHDRAWING THE CORE NEEDLE, AND REMOVAL OF THE CATHETER IT WAS FOUND THAT THE CATHETER WAS KINKED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND FLOW RATE SLOW AFTER WITHDRAWING THE CORE NEEDLE, REMOVAL THE CATHETER FINDING THE CATHETER KINK.

    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 DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, THE FLOW RATE WAS SLOW AFTER WITHDRAWING THE CORE NEEDLE, AND REMOVAL OF THE CATHETER IT WAS FOUND THAT THE CATHETER WAS KINKED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND FLOW RATE SLOW AFTER WITHDRAWING THE CORE NEEDLE, REMOVAL THE CATHETER FINDING THE CATHETER KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356471 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8043022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other