BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8466233 · Received March 29, 2019

    Report

    Report Number
    3006948883-2019-00227
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 8, 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 7142446. 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. 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 AN BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM "ON THE EVENING OF MARCH 8, WHEN THE PATIENT WAS CARED FOR, THE CATHETER SEAT WAS STILL LEFT ON THE FOOT, BUT THE CATHETER WAS GONE, AND IT WAS FOUND AROUND THE BED, BUT IT WAS STILL NOT FOUND. A WHOLE BODY SCAN WAS PERFORMED, AND NO CATHETER WAS FOUND IN THE BODY SO FAR."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF AN BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM "ON THE EVENING OF (B)(6), WHEN THE PATIENT WAS CARED FOR, THE CATHETER SEAT WAS STILL LEFT ON THE FOOT, BUT THE CATHETER WAS GONE, AND IT WAS FOUND AROUND THE BED, BUT IT WAS STILL NOT FOUND. A WHOLE BODY SCAN WAS PERFORMED, AND NO CATHETER WAS FOUND IN THE BODY SO FAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258562 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7142446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention