BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FX20CM TRIPLE LUMEN CATH

    MDR report key: 2771668 · Received September 28, 2012

    Report

    Report Number
    2518902-2012-00064
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDCOMP
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUTURE WING OF THE RETURNED DEVICE WAS REASSEMBLED ON THE HUB AND THE FORCE TO REMOVE IT WAS MEASURED. THE FORCE REQUIRED TO REMOVE THE SUTURE WING WAS GREATER THAN ISO 10555-1 REQUIREMENT. THERE IS NO EVIDENCE OF A MANUFACTURING PROBLEM. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT; HOWEVER IT APPEARS THAT ENOUGH FORCE WAS APPLIED TO THE CATHETER TO DISLODGE IT FROM THE SUTURE WING.

    Description of Event or Problem · 1

    "THE SUTURE HUB HAS LOOSEN FROM THE CATHETER, SO THE CATHETER HAS SLIDE OUT OF THE PT APPROX. 15CM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.5FX20CM TRIPLE LUMEN CATH HEMODIALYSIS CATHETER DQO MEDCOMP XTP3118MTE MBJL520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention