BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8472107 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00008
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Removal / Correction Number
    Z-0179-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS ABLE TO VERIFY THE OBSERVATION OF THE 5CM PRINT MARK BEING OFF MY ONE CENTIMETER AND APPEARING AT 4CM FROM THE TIP. RELYING ON JUST THE PRINT MARKING TO POSITION THE CATHETER WOULD LEAVE THE CATHETER UNDER-INSERTED, MEANING THAT INSERTING TO THE 5CM MARK WOULD ONLY PLACE THE CATHETER 4CM DEEP. THE INSTRUCTIONS FOR USE REQUIRE THE USER TO "VERIFY POSITION OF THE CATHETER IN THE RIGHT ATRIUM USING X-RAY OR ULTRASOUND." THE PRINTING ERROR WAS A RESULT OF THE DRAWING BEING INCORRECTLY DIMENSIONED ANDN THE ERROR WAS NOT NOTICED WHEN THE DRAWING WAS APPROVED. THE DRAWING HAS BEEN CORRECTED FOLLOWING NOTICE OF THIS INCIDENT/MALFUNCTION.

    Description of Event or Problem · 1

    THE PRINT NUMBER ON THE CATHETER IS OFF BY 1CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269578 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV13F R19506

    Patients

    Seq Age Sex Outcome Treatment
    1