BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TPN CATHETER SET

    MDR report key: 1032210 · Received April 18, 2008

    Report

    Report Number
    1820334-2008-00204
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 26, 2008
    Report Date
    March 19, 2008
    Manufacturer
    COOK INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. THEREFORE, WE WERE NOT ABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THIS EVENT. OUR QC DEPT CONFIRMS THE OVERALL CATHETER SURFACE OF THIS PRODUCT IS CLEAN AND WITHOUT EXCESSIVE IMPERFECTIONS OR DAMAGE. WE DO CAUTION THAT SILICONE CATHETERS ARE NOT DESIGNED FOR POWER INJECTION AS THE CATHETER MAY RUPTURE. USE OF A 10ML SYRINGE OR LARGER WILL REDUCE THE RISK OF CATHETER RUPTURE. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES.

    Description of Event or Problem · 1

    THE LINE WAS INSERTED IN 2007. THE LINE FRACTURED IN 2008, AND WAS REPAIRED. A SECOND FRACTURE OCCURRED TWO DAYS LATER, IN A NEW SPOT ON THE LINE. THE PREVIOUS REPAIR REMAINED INTACT. A SECOND REPAIR WAS CONDUCTED. THERE WAS NO OTHER IMPACT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK TPN CATHETER SET DQY SPECIAL SET DQY COOK INC NA F2124606

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other