BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD 8F CATHETER

    MDR report key: 3443499 · Received September 19, 2013

    Report

    Report Number
    2025816-2013-00111
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    July 3, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED CATHETER RECORDED THE RA PROXIMAL TUBING WAS BROKEN BELOW THE BOND AT THE CATHETER MANIFOLD. THE TUBING HAD SIGNS OF DAMAGE (STRETCHING) TYPICAL OF EXTREME TENSILE FORCES. FURTHER ANALYSIS OF THE CATHETER COMPONENT SEPARATION RECORDED THE BOND WAS STILL COMPLETELY INTACT AFTER THE BREAK. BASED ON THE "AS-RECEIVED" CONDITION OF THE 41217-02 TD CATHETER THE REPORTED PRODUCT ISSUE WAS CONFIRMED. ADDITIONAL ENGINEERING TESTING AND ANALYSIS WAS PERFORMED. THE RETURNED CATHETERS' REMAINING LUMEN AND DISTAL TUBING LINES WERE EACH TESTED FOR TENSILE FORCE REQUIRED TO PULL THE TUBING LINES FROM THE MANIFOLD. THE RESULT RECORDED EACH OF THE REMAINING TUBING LINES RECORDED VALUES WELL ABOVE THE SPECIFICATION REQUIREMENT FOR TUBING-CATHETER BONDS. RECORD REVIEW: A THREE YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST#/SIMILAR PRODUCT ISSUE RECORDED NO ADDITIONAL REPORTS. FINDING: THE REPORTED PRODUCT ISSUE (COMPONENT BREAKAGE) WAS VISUALLY CONFIRMED WITH THE "AS-RECEIVED" 41217-02 TD CATHETER. BASED ON THE FACILITIES INTERNAL INVESTIGATION AND THE MFRS ENGINEERING ANALYSIS OF THE RETURNED CATHETER THE ROOT CAUSE OF THE PRODUCT ISSUE WAS FOUND TO BE ATTRIBUTABLE TO UNINTENDED FORCE/USAGE. THE DEVICE MANUFACTURER HAS PROVIDED THE REPORTING FACILITY WITH THIS DEVICE INVESTIGATION REPORT/W PHOTOGRAPHS FOR THEIR REVIEW AND UNDERSTANDING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED. CONCERNING DEVICE / COMPONENT BREAKAGE WITH USE OF ONE 41217-02, 8F 5 LUMEN CATHETER, LOT# UNK. IT WAS REPORTED THAT THE CATHETER "CVP LINE BROKE OFF WITH MINIMAL PRESSURE APPLIED." F/U INFO OBTAINED REPORTS FACILITIES INTERNAL INVESTIGATION FOUND THAT THE "CATHETER (LINES) WERE CAUGHT IN THE BED RAIL AND WITH MINIMAL STRESS, BROKE". THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. DEVICE RETURN: ONE USED 41217-02 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474527 TD 8F CATHETER CATHETER FOZ ICU MEDICAL, INC. 41217-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1