BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F TD CATHETER

    MDR report key: 8587656 · Received February 6, 2014

    Report

    Report Number
    2025816-2014-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 17, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE RETURNED 41239-06 CATHETER THE REPORTED BALLOON INFLATION ISSUE WAS VERIFIED. THE· EXACT CAUSE(S) HOWEVER ARE UNKNOWN AT THIS TIME. THE MFR. WILL CONTINUE TO MONITOR AND TREND AND IMPLEMENT ANY PREVENTATIVE OR CORRECTIVE ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING A CATHETER BALLOON INFLATION ISSUE WITH USE OF ONE 41239-06 7F TO CATHETER. THE 41239-06 7F CATHETER WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT WHERE NO INFLATION ISSUES/ANOMALIES WERE ENCOUNTERED. THE FACILITY REPORTED "CATHETER IN A PATIENT FOR ABOUT 4 MINUTES, FLOATING INTO POSITION. WEDGE.." WHEN THE CATHETER BALLOON FAILED ·TO MAINTAIN INFLATION.". THE CATHETER WAS REMOVED AND REPLACED WHERE NO FURTHER ISSUES WERE ENCOUNTERED. THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCES. DEVICE RETURN: ONE (1) USED 41239-06 7F CATHETER WAS RETURNED TO THE MFR. MFRS INVESTIGATION: VISUAL INSPECTION AND ANALYSIS OF THE AS-RECEIVED 41239-06 7 FR CATHETER RECORDED THE BALLOON WAS DAMAGED/ TORN. THERE WAS NO MISSING BALLOON MATERIAL/FRAGMENTS. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. ADDITIONAL ENGINEERING ANALYSIS OF THE RETURNED CATHETER COMPONENTS IDENTIFIED NO MANUFACTURING DEFECTS, DIMENSIONAL NON-CONFORMANCES AND OR OUT OF SPEC CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE PRODUCT ISSUE. A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOTI 30-988-SJ (MFG. DATE (08/2013) SHOWS (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
    76596 7F TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41239-06 30-988-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI