BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN PED-SOFT UNCUFFED ET TUBE

    MDR report key: 2932459 · Received January 24, 2013

    Report

    Report Number
    3003898360-2013-00049
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES HAVING DIFFICULTY PASSING A 6 FR BALLARD CATHETER THROUGH THE ENDOTRACHEAL TUBE. RESISTANCE IS MET AT THE TIP OF THE ENDOTRACHEAL TUBE. ONE BABY WAS RE-INTUBATED BECAUSE OF THIS ISSUE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34559 HUDSON SHERIDAN PED-SOFT UNCUFFED ET TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01F1200412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLARD 6FR CATHETER