BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SOFT SIMPLASTIC 3-WAY CATHETER

    MDR report key: 2043458 · Received February 25, 2011

    Report

    Report Number
    8040412-2011-00019
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 REPORTED AS: FOLLOWING BLADDER SURGERY, THE BALLOON DEFLATED AND FELL OUT OF THE PT APPROX. SIX HOURS AFTER INSERTION. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SOFT SIMPLASTIC 3-WAY CATHETER UROLOGICAL CATHETER KOD TELEFLEX MEDICAL NA 101E39

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK