BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDCH, 4L, 110CM, CATHETER

    MDR report key: 1833092 · Received May 11, 2010

    Report

    Report Number
    2025816-2010-00048
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    November 19, 2009
    Report Date
    December 4, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING BALLOON INFLATION FAILURE WITH ONE (1) 41239-06 PA CATHETERS. THE DEVICE WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT WITH NO PROBLEMS NOTED. LIMITED INFORMATION AVAILABLE AS TO LENGTH OF TIME THE DEVICES WERE IN USE, WHETHER ANY UNUSUAL INSERTION/FLOATING PROBLEMS WERE ENCOUNTERED, IDENTITY, MODEL AND SIZE OF ANCILLARY ACCESSORY DEVICES, SHEATHS, CONTAMINATION SHIELDS ETC. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. MFR'S INVESTIGATION AND ANALYSIS: ONE (1) USED 41239-06 CATHETER WAS RECEIVED AND PROCESSED AT THE ICU MEDICAL (B)(4) FACILITY. THE INVESTIGATION IS SUMMARIZED BELOW: VISUAL INSPECTION AND ANALYSIS WAS PERFORMED. THE CATHETER BALLOON WAS EXAMINED UNDER A MICROSCOPE AT 10X MAGNIFICATION. THE RESULTS RECORDED THAT THE CATHETER BALLOON MATERIAL WAS INDEED TORN/DAMAGED. CONCLUSION: ALTHOUGH THE EXACT CAUSE(S) OF THE BALLOON TEARS/DAMAGES ARE UNKNOWN, THE ENGINEERING ANALYSIS REPORT CITES THIS TYPE OF DAMAGE HAS BEEN REPLICATED/CAN OCCUR AS A RESULT OF OVER-INFLATION OR PENETRATION WITH A SHARP INSTRUMENT/OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDCH, 4L, 110CM, CATHETER PA CATHETER DYG ICU MEDICAL, INC. 41239-06 77-385-R5

    Patients

    Seq Age Sex Outcome Treatment
    1