BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SILICONE 3WAY CATHETER, 22FR

    MDR report key: 1944223 · Received December 6, 2010

    Report

    Report Number
    8040412-2010-00110
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON WAS FOUND BROKEN THREE DAYS AFTER ITS INSERTION. ANOTHER CATHETER WAS INSERTED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH 100% SILICONE 3WAY CATHETER, 22FR UROLOGICAL CATHETER KOD TELEFLEX MEDICAL NA 10GE30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK