BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TD CATHETER

    MDR report key: 4177328 · Received September 8, 2014

    Report

    Report Number
    2025816-2014-00101
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD AND DFU LABEL REVIEWS: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 40-535-HE (MFG. DATE (05/01/2014) SHOWS (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. THE CATHETERS DIRECTION FOR USE (DFU) PROVIDES SPECIFIC INSTRUCTIONS FOR REQUIRED SIZED ACCESSORY DEVICES AND IDENTIFIES THIS CATHETER REQUIRES ANCILLARY DEVICES (INTRODUCERS/CONTAMINATION SHIELD) SIZE OF 8.5F OR "RETEST THE BALLOON FOR PROPER FUNCTION AFTER INSERTION THROUGH THE SHIELD". FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE RETURNED 41237-05 8F CATHETER THE REPORTED BALLOON INFLATION ISSUE WAS VERIFIED. THE ROOT CAUSE OF THE CATHETER INFLATION PROBLEM WAS DUE TO THE DAMAGES TO THE BALLOON COMPONENT. THE DAMAGES MOST LIKELY ARE A RESULT OF CONTRAINDICATED USE OF AN INCORRECT SIZE CONTAMINATION SHIELD. THE INVESTIGATION REPORT, PHOTOGRAPHS AND THE DIRECTIONS FOR USE (DFU) WILL BE PROVIDED TO THE FACILITY FOR THEIR REVIEW AND STAFF TRAINING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH USE OF ONE 41237-05 8F HEPARIN COATED TD CATHETER. THE CATHETER WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT OF ARROW #ST-09807 CONTAMINATION SHIELD. AT AN UNSPECIFIED TIME DURING THE PROCEDURE THE BALLOON "BURST". THE CATHETER WAS REMOVED/REPLACED WITH NO FURTHER INCIDENT. THERE WAS NO REPORTED ADVERSE PT. CONSEQUENCES AND OR OUTCOMES. DEVICE RETURN: ONE USED 41237-05 8F CATHETER WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) OF THE CATHETER WAS PERFORMED. THE RESULTS RECORDED THE CATHETER BALLOON WAS DAMAGED AT THE POINT OF PROPAGATION, PERPENDICULAR TO THE AXIS OF THE CATHETER. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. THE ENGINEERS EVALUATION/SEARCH OF THE RETURNED ARROW #ST-09807 CONTAMINATION SHIELD HAS PREVIOUSLY DOCUMENTED THIS DEVICE MODEL IS FOR USE WITH 7/7.5 F CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550381 8F TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41237-05 40-535-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARROW #(B)(4) CONTAMINATION SHIELD