BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F TD CATHETER

    MDR report key: 3598065 · Received November 13, 2013

    Report

    Report Number
    2025816-2013-00120
    Event Type
    Malfunction
    Date Received
    November 13, 2013
    Date of Event
    August 15, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFR LOT BUILD DATABASE FOR THE REPORTED LOT# 28-602-SL (MFR 06/01/2013) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE RETURNED 41229-01 CATHETER THE REPORTED INFLATION ISSUE WAS VERIFIED. ALTHOUGH THE EXACT CAUSE(S) OF THE CATHETER BALLOON INFLATION PROBLEM ARE UNKNOWN USE OF AN INCORRECT SIZE INTRODUCER MOST LIKELY CAUSED OR CONTRIBUTED TO THE BALLOON TEARS/DAMAGES.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING CATHETER BALLOON INFLATION ISSUE WITH USE OF ONE 41229-01 7F TD CATHETER. THE 41229-01 7F CATHETER WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT WHERE NO INFLATION ISSUES/ANOMALIES WERE ENCOUNTERED. THE FACILITY REPORTED "...BURST AFTER IT WAS TESTED (WITH AIR) AND THEN PLACED INTO A PATIENT." THE CATHETER WAS REMOVED AND REPLACED WHERE NO FURTHER ISSUES WERE ENCOUNTERED. THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCES. DEVICE RETURN STATUS: VISUAL INSPECTION AND ANALYSIS OF THE AS-RECEIVED 41229-01 7 FR CATHETER RECORDED THE BALLOON WAS EXTENSIVELY DAMAGE/TORN. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. FOLLOW-UP INFORMATION OBTAINED FROM THE FACILITY REPORTED A 7FR INTRODUCER WAS USED WITH THE 412229-01 7FR CATHETER. THE 41229-01 CATHETERS DIRECTION FOR USE (DFU) PROVIDES SPECIFIC INSTRUCTIONS FOR REQUIRED SIZED ACCESSORY DEVICES AND IDENTIFIES THIS CATHETER REQUIRES INTRODUCER SIZE OF 8F OR LARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589408 7F TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41229-01 28-602-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 NI 7 FR INTRODUCER, MFR MAKE/MODEL UNKNOWN