BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 6FR 100% SILICONE FOLEY

    MDR report key: 3042830 · Received April 4, 2013

    Report

    Report Number
    8040412-2013-00060
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 13, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFR IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: CATHETER TUBING SNAPPED OFF AT THE CONNECTION TO THE CATHETER HUB DURING A PROCEDURE. THE CATHETER WAS REPLACED WITHOUT INCIDENT. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138017 RUSCH 6FR 100% SILICONE FOLEY FOLEY CATHETER KOD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1