BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBRAUN 16 FR 2-WAY CATHETER 30 CC

    MDR report key: 2993008 · Received March 1, 2013

    Report

    Report Number
    8040412-2013-00047
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 6, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED BY MFR IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: WHEN THE STAFF WAS USING THE DEVICE, THEY FOUND THE BALLOON WAS LEAKING. NO REPORTED INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89394 BBRAUN 16 FR 2-WAY CATHETER 30 CC FOLEY CATHETER EZL TELEFLEX MEDICAL 10C10

    Patients

    Seq Age Sex Outcome Treatment
    1