BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SIMPLASTIC 3WAY 30CC 24F

    MDR report key: 3023084 · Received February 25, 2013

    Report

    Report Number
    8040412-2013-00041
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    November 1, 2012
    Report Date
    February 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE STAFF REPORTED THAT A RETENTION BALLOON DEFLATED BEFORE THE DOCTOR WAS PREPARED TO REMOVE THE CATHETER. THERE HAVE BEEN NO INJURY OR RISKS ASSOCIATED WITH THE BALLOON DEFLATING AS THE CATHETERS WERE ONLY TO BE USED SHORT TERM POST-OP. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81056 RUSCH SIMPLASTIC 3WAY 30CC 24F FOLEY CATHETER KOD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1