BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDCH, 4L, 110CM, CATHETER HTR KIT

    MDR report key: 1833089 · Received May 11, 2010

    Report

    Report Number
    2025816-2010-00045
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    July 20, 2009
    Report Date
    July 31, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D. REPORTING BALLOON INFLATION PROBLEM WITH ONE (1) (B)(4) PA CATHETER. THE REPORT STATES "THE BALLOON WAS TESTED DURING PRE-INSERTION TESTING AND THE BALLOON PASSED TESTING. THE CATHETER WAS PLACED IN THE PATIENT WITHOUT ANY DIFFICULTY. THE CLINICIAN ATTEMPTED TO PERFORM A WEDGE PRESSURE AND WAS UNABLE TO WEDGE THE BALLOON. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS INTACT." THE DEVICE WAS REMOVED AND REPLACED WITH NO REPORTED ADVERSE PATIENT CONSEQUENCES OR DELAY IN CRITICAL THERAPY. THE INVOLVED DEVICE WAS DISCARDED. A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 75-648-YJ (MFG DATE 03/2009) SHOWS 500 UNITS WERE MFG., TESTED, INSPECTED, & RELEASED. CONCLUSION: THE INVOLVED (B)(4) CATHETER DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION. EXACT CAUSE(S) OF THE EVENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDCH, 4L, 110CM, CATHETER HTR KIT PA CATHETER FOZ ICU MEDICAL, INC. 41239-06 75-648-YJ

    Patients

    Seq Age Sex Outcome Treatment
    1