BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9412101 · Received December 4, 2019

    Report

    Report Number
    3006948883-2019-01021
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 3, 2019
    Report Date
    December 30, 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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050871. 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. 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 HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING BLOOD BACKFLOW DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: 2019.11.03 CHILDREN NEED INTRAVENOUS FLUIDS, PRESCRIBED FOR CHILDREN WITH INTRAVENOUS INDWELLING NEEDLE, CHECK THE NEEDLE WITHOUT EXCEPTION, AFTER THE SUCCESS OF THE PUNCTURE, IV HEPARIN CAP FOR COHESION NOT CLOSE OFF, LEAD TO CHILDREN WITH VENOUS BLOOD BACKFLOW, STRAINING CHILDREN AND THEIR FAMILIES.

    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 HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING BLOOD BACKFLOW DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: (B)(6) 2019 CHILDREN NEED INTRAVENOUS FLUIDS, PRESCRIBED FOR CHILDREN WITH INTRAVENOUS INDWELLING NEEDLE, CHECK THE NEEDLE WITHOUT EXCEPTION, AFTER THE SUCCESS OF THE PUNCTURE, IV HEPARIN CAP FOR COHESION NOT CLOSE OFF, LEAD TO CHILDREN WITH VENOUS BLOOD BACKFLOW, STRAINING CHILDREN AND THEIR FAMILIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208811 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other