BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 2 WAY SILICONE CATHETER

    MDR report key: 3813219 · Received March 31, 2014

    Report

    Report Number
    8040412-2014-00082
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 10, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: "PATIENT CAME FROM ER TO THE WARD WITH CATHETER IN PLACE. LATER ON IT IS DISCOVERED THAT THE CATHETER BROKE BELOW THE CROTCH." NO REPORTED PATIENT INJURY. CONDITION OF PATIENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189910 RUSCH 2 WAY SILICONE CATHETER FOLEY CATHETER BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1