BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON TUBING, STAR LUMEN, 7'

    MDR report key: 3813228 · Received March 31, 2014

    Report

    Report Number
    3004365956-2014-00161
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS PERFORMED ON A PICTURE PROVIDED BY THE CUSTOMER. IT CAN BE OBSERVED A KINKED TUBE. NO OTHER ISSUES WERE FOUND. DIMENSIONAL AND FUNCTIONAL INSPECTION IS NOT REQUIRED SINCE THE REPORTED ISSUE IS NOT RELATED TO A DIMENSIONAL DEFECT. A DHR (DEVICE HISTORY RECORD) REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO THIS ISSUE NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. DURING THE VISUAL INSPECTION OF THE PICTURE PROVIDED BY THE CUSTOMER AND REPORTED DEFECT IS CONFIRMED, THE PRODUCT (CATALOG #1112) HAS A KINKED TUBE. REGARDING THE KINKED ISSUE, THE TRANSPORTATION CARTS THAT ARE CURRENTLY USED TO STAGE THE TUBING FROM EXTRUSION INTO ASSEMBLY WILL BE IMPROVED TO AVOID KINKS DURING HANDLING.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT UPON OPENING THE PACKAGE THE STAFF NOTED THE TUBING BENT, TWISTED AND CRUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190026 HUDSON TUBING, STAR LUMEN, 7' OXYGEN TUBING CAT TELEFLEX 02A1400805

    Patients

    Seq Age Sex Outcome Treatment
    1