BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD 2WAY PED SIL 3CC 8F

    MDR report key: 4101988 · Received September 15, 2014

    Report

    Report Number
    8040412-2014-00207
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 21, 2014
    Manufacturer
    TELEFLEX
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MFR AT THE TIME OF THIS REPORT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: IT WAS REPORTED THAT SOME OF THE CATHETERS FROM THIS WERE FOUND BY THE MEDICAL STAFF TO BE BLOCKED. THERE WAS NO REPORTED PT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569170 GOLD 2WAY PED SIL 3CC 8F FOLEY CATHETER EZL TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1