BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD CATHETER

    MDR report key: 3938234 · Received March 3, 2014

    Report

    Report Number
    2025816-2014-00018
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 20, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED LOT# 30-988-SJ (MFG DATE 08/2013) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE TWO RETURNED 41239-06 CATHETER THE REPORTED BALLOON INFLATION ISSUE WAS VERIFIED. THE EXACT CAUSE(S) HOWEVER, ARE UNK AT THIS TIME. THE MFG WILL CONTINUE TO MONITOR AND TREND AND IMPLEMENT ANY PREVENTATIVE OR CORRECTIVE ACTIONS AS APPROPRIATE. DEVICE RETURN: TWO (2) USED 41239-06 6F CATHETER WAS RETURNED TO THE MFR. MFR'S INVESTIGATION: VISUAL INSPECTION AND ANALYSIS OF THE TWO AS-RECEIVED 41239-06 7 FR CATHETERS RECORDED THE BALLOONS WERE DAMAGED/TORN. THERE WERE NO MISSING BALLOON MATERIAL/FRAGMENTS. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. ADD'L ENGINEERING ANALYSIS OF THE RETURNED CATHETER COMPONENTS IDENTIFIED ON MFG DEFECTS, DIMENSIONAL NON-CONFORMANCES AND OR OUT OF SPEC CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE PRODUCT ISSUE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING BALLOON INFLATION FAILURES WITH TWO 41239-06 7F TO HEPARIN COATED CATHETERS. IT WAS REPORTED THAT AT UNSPECIFIED TIME DURING THE PROCEDURE, A CATHETER INFLATION FAILURE OCCURRED. THE CATHETER WAS REMOVED AND A SECOND 41239-06 CATHETER WAS PLACED WHICH ALSO FAILED TO MAINTAIN INFLATION AND WAS REMOVED. A THIRD CATHETER WAS PLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126062 TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41239-06 30-988-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI