BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE-LINE CATHETER

    MDR report key: 3381273 · Received September 3, 2013

    Report

    Report Number
    2025816-2013-00115
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    August 3, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: VISUAL INSPECTION AND ANALYSIS OF THE RETURNED COMPLAINT SAMPLES RECORDED BOTH OF THE RETURNED USED CATHETERS BALLOON COMPONENTS WERE EXTENSIVELY DAMAGED/TORN. DURING DECONTAMINATION FLUSHING, THE RETURNED 3ML SYRINGE STOPPERS WERE NOTED AS NOT FUNCTIONING PROPERLY. BASED ON THE VISUAL INSPECTION AND ANALYSIS OF THE "AS-RECEIVED" 41233-02 CATHETER AND SYRINGE DEVICES THE PRODUCT ISSUES WERE CONFIRMED. ADD'L REVIEW OF THE 41233-02 CATHETER, LOT# 16-956-SL CONFIRMS THE DEVICE WAS USED AFTER ITS LABEL EXP DATE. THE 41233-02 CATHETER BALLOON FINDINGS: AS PART OF THE MFR'S CONTINUOUS IMPROVEMENT INITIATIVES A MULTI-DISCIPLINE TEAM WAS INITIATED TO PERFORM IN-DEPTH ANALYSIS OF INTERMITTENT CATHETER BALLOON INFLATION ISSUES. FUNCTIONAL DATA OBTAINED FROM PRODUCTION LOTS AND ENGINEERING STUDIES WERE REVIEWED. NO TRENDS/FAILURES IN PERFORMANCE WERE FOUND. A REVIEW AND ANALYSIS OF RAW MATERIAL DATA WAS CONDUCTED. THE ANALYSIS NOTED THAT NEW LOTS OF THE BALLOON MATERIAL (POLYISOPRENE) ARE RECEIVED EVERY 6 MONTHS, BUT CONSUMPTION CAN VARY BASED ON ORDER DEMANDS. POTENTIAL ROOT CAUSE: POLYISOPRENE IS CONTINUALLY AGING, BALLOONS MFG WITH OLDER MATERIAL, WHEN SUBJECTED TO CERTAIN CONDITIONS (SHIPPING, HEAT, ETC.) MAY EXPERIENCE MATERIAL DEGRADATION/DETERIORATION. MINOR MODIFICATIONS TO THE BALLOON MATERIAL FORMULATION ARE IN VARIOUS STAGES OF QUALIFICATIONS AND VALIDATIONS. THE ENGINEERING TEST DATA TO DATE INDICATES THIS FORMULATION SHOWS VIABLE IMPROVEMENTS. THE 3ML SYRINGE FINDINGS: ENGINEERING ANALYSIS OF THE RETURNED 3ML SYRINGE IDENTIFIED THAT THE STOPPERS MOLDED INTO THE COMPONENT BODY WERE DEFECTIVE/UNDERSIZED AND DID NOT ACCURATELY STOP THE PLUNGER. THE TWO ADDITIONAL 3ML SYRINGES RETURNED WITH THE CATHETER SET-UPS RECORDED NO FUNCTIONAL, PERFORMANCE OR MFG ANOMALIES. ROOT CAUSE WAS ATTRIBUTABLE TO AN ISOLATED MFG ERROR. CONCLUSIONS: THE REPORTED PRODUCT ISSUES, BALLOON LEAKAGE AND SYRINGE FUNCTIONALITY WERE CONFIRMED. HEIGHTENED TESTING, INSPECTION AND INTERNAL VERIFICATION AUDITS WERE INITIATED AND IMPLEMENTED. ADDITIONAL EXP DATE: 12/2013. ADDITIONAL DEVICE MFR DATE: 12/2012.

    Description of Event or Problem · 1

    INT'L (B)(6) COMPLAINT RECEIVED CONCERNING CATHETER BALLOON INFLATION ISSUES WITH USES OF THREE (3) 41233-02 8FR TD CATHETERS FROM TWO DIFFERENT LOT# 16-956-SL AND 23-278-SL. ADDITIONALLY IT WAS REPORTED THAT ONE OF THE 3ML SYRINGES ACCESSORY DEVICES INCLUDED IN THE CATHETER KITS WAS DEFECTIVE. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. DEVICE RETURN: TWO (2) USED 41233-02, 8FR HEPARIN COATED TD CATHETER SET-UPS; ONE (1) 3ML MONOJECT BALLOON SYRINGE AND ONE (1) UNIDENTIFIED TUBING EXTENSION SET; NEEDLEFREE CONNECTORS WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436434 TD TORQUE-LINE CATHETER PA CATHETER DYG ICU MEDICAL, INC. 41233-02 16-956-SL, 23-278-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 NI