BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIEMAN CATHETER 100% SILICONE 2WAY 5CC

    MDR report key: 2182514 · Received July 8, 2011

    Report

    Report Number
    8040412-2011-00105
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE CATHETER WAS DIFFICULT TO REMOVE FROM PATIENT. IT WAS NOTICED BY THE NURSE THAT THE BALLOON WAS "FOLDED." THE NURSE HAD TO CUT THE CATHETER SHAFT AT THE BIFURCATION. THE CATHETER WAS IN PLACE SEVEN DAYS BEFORE HAVING TO BE REMOVED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIEMAN CATHETER 100% SILICONE 2WAY 5CC FOLEY CATHETER KOD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK