BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLITE DISP METAL MAC 3

    MDR report key: 3963209 · Received May 20, 2014

    Report

    Report Number
    1044475-2014-00137
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CLINICIAN WAS ATTEMPTING TO INTUBATE A PATIENT AND THE BLADE LIGHT PIPE COMPLETELY BROKE WHICH RESULTED IN A DISRUPTION OF LIGHT TRANSMISSION. THE PIPE BUNDLE BROKE IN THE CURVE AS THE BUNDLE WAS LEAVING THE BASE OF THE BLADE. THERE WAS NO REPORT OF BROKEN PIECES OF PLASTIC ENTERING THE PATIENT'S MOUTH. THE CLINICIAN REPLACED THE BROKEN BLADE WITH ANOTHER FUNCTIONING BLADE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298397 RUSCH EQUIPLITE DISP METAL MAC 3 CCW TELEFLEX 1401732

    Patients

    Seq Age Sex Outcome Treatment
    1