BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F TD CATHETER

    MDR report key: 4865025 · Received June 23, 2015

    Report

    Report Number
    2025816-2015-00059
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    March 30, 2015
    Report Date
    May 15, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: THE INVOLVED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION. PRIOR TO PLACEMENT THE CATHETER DEVICE WOULD HAVE BEEN PRE-TESTED WHICH INCLUDES INFLATION INTEGRITY TESTING. IT IS UNKNOWN IF THE INSTRUCTIONS IN THE CATHETER DIRECTIONS FOR USE FOR DEFLATING THE BALLOON, OPENING THE STOPCOCK AND REMOVING THE INFLATION SYRINGE WERE FOLLOWED.

    Description of Event or Problem · 1

    (B)(6) INCIDENT REPORT RECEIVED REPORTING BALLOON DEFLATION FAILURE WITH USE OF ONE 011-41229-01 7F TD CATHETER. IT WAS REPORTED "THE BALLOON CATHETER IS NOT DEFLATED EVEN WHEN IE DEFLATION VALVE REMAINS OPEN". THE REPORT DID INDICATE THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THE CATHETER DEVICE WOULD HAVE BEEN PRE-TESTED WHICH INCLUDES INFLATION INTEGRITY TESTING PRIOR TO PLACEMENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THE MFGERS. FOLLOW UP REQUESTS FOR ADDITIONAL EVENT INFORMATION AND DEVICE RETURN STATUS. INVESTIGATION: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 2884813 (MFG. DATE 06/2014) SHOWED (B)(4) UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407092 7F TD CATHETER TD CATHETER FPA ICU MEDICAL, INC. 011-41229-01 2918716

    Patients

    Seq Age Sex Outcome Treatment
    1 NI