BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F TD CATHETER

    MDR report key: 4120668 · Received July 28, 2014

    Report

    Report Number
    2025816-2014-00086
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 23, 2014
    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

    DEVICE RETURN: ONE USED 41229-01 7FR. TD CATHETER WAS RETURNED. ALTHOUGH REQUESTED THE INVOLVED ANCILLARY DEVICES, I.E. INTRODUCERS, CONTAMINATION SHIELD WERE NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) OF THE 41229-01 7 FR CATHETER WAS PERFORMED. THE RESULTS RECORDED THE CATHETER BALLOON WAS DAMAGED/GAUGED TEAR. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. ADDITIONAL ENGINEERING ANALYSIS OF THE CATHETER COMPONENTS IDENTIFIED NO MFG. DEFECTS, DIMENSIONAL NON-CONFORMANCES AND/OR OUT OF SPEC CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE PRODUCT ISSUE. RECORD AND DFU LABEL REVIEWS: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT #38-341-SJ (MFG. DATE (03/2014) SHOWS (B)(4)UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. USAGE INFORMATION REPORTS A 7FR INTRODUCER WAS USED WITH THE 41229-01 7FR CATHETER. THE CATHETERS DIRECTION FOR USE (DFU) PROVIDES SPECIFIC INSTRUCTIONS FOR REQUIRED SIZED ACCESSORY DEVICES AND IDENTIFIES THIS CATHETER REQUIRES INTRODUCER SIZE OF 8F OR LARGER. FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE RETURNED 41229-01 CATHETER THE REPORTED BALLOON INFLATION ISSUE WAS VERIFIED. THE ROOT CAUSE OF THE CATHETER BALLOON INFLATION PROBLEM WAS DUE TO THE DAMAGE TO THE BALLOON. THE DAMAGES MOST LIKELY ARE A RESULT OF CONTRAINDICATED USE OF AN INCORRECT SIZE INTRODUCER. THE INVESTIGATION REPORT, PHOTOGRAPHS AND HIGHLIGHTED SECTIONS OF THE DIRECTIONS FOR USE (DFU) HAVE BEEN PROVIDED TO THE FACILITY CONTACTS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH USE OF ONE (B)(4) HEPARIN COATED CATHETER. THE CATHETER WAS SUCCESSFULLY PRE-TESTED PRIOR TO USE OF 7FR. INTRODUCER (MFGER. MODEL NOT REPORTED). THE INCIDENT WAS REPORTED AS FOLLOWS "...BALLOON RUPTURE AFTER INSERTION..." THE CATHETER WAS REMOVED/REPLACED WITH NO FURTHER INCIDENT. THERE WAS NO REPORTED ADVERSE PT. CONSEQUENCES AND/OR OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439802 7F TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41229-01 38-341-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI