BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TPN DOUBLE LUMEN TPN CATHETER

    MDR report key: 3760946 · Received April 9, 2014

    Report

    Report Number
    1820334-2014-00151
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COOK INC
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER INFORMATION SUPPLIED BY THE CUSTOMER. FINAL INSPECTION FOR TPN MULTI LUMEN CATHETER CONFIRMS THAT EACH EXTENSION, MAIN CATHETER SHAFT AND, IF SPECIFIED, STRAIN RELIEF TUBING ARE SECURELY MOLDED TO MANIFOLD WITHOUT VOIDS OR CRACKS AND CONFIRMS CORRECT PROXIMAL FITTINGS HAVE BEEN SECURELY ATTACHED, AND CONFIRMS OVERALL CATHETER SURFACE IS CLEAN AND FREE OF DAMAGE OR EXCESSIVE IMPERFECTIONS. THIS PRODUCT IS SHIPPED WITH AN IFU WHICH STATES WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR USE. WE ARE INCONCLUSIVE AS TO WHY THIS FAILURE MODE OCCURRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. PER RISK ASSESSMENT, ADDITIONAL ACTION IS NOT REQUIRED AT THIS TIME BASED ON THE ASSOCIATED RISK.

    Description of Event or Problem · 1

    LINE FRACTURED ON PATIENT SIDE OF LUMEN BIFURCATION ON A CENTRAL LINE THAT WAS ALREADY IN PLACE. AFTER DIFFICULTY, THE LINE WAS REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213272 COOK TPN DOUBLE LUMEN TPN CATHETER FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS LJS COOK INC NA 3845007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention