BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SILICONE TIEMANN CATHETER, 2-WAY, 5CC

    MDR report key: 1930171 · Received November 22, 2010

    Report

    Report Number
    8040412-2010-00096
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CATHETER WAS EXPELLED BECAUSE THE CUFF SPLIT AND DEFLATED 2-3 DAYS AFTER ITS INSERTION IN A PATIENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SILICONE TIEMANN CATHETER, 2-WAY, 5CC UROLOGICAL CATHETER KOD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK