BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERIDAN PED-SOFT

    MDR report key: 2111952 · Received May 29, 2011

    Report

    Report Number
    2111952
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 29, 2011
    Manufacturer
    TELEFLEX MEDICAL HUDSON RCI
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON SUCTIONING THIS PATIENT, THE RT RESPIRATORY THERAPIST / RN FELT RESISTANCE AT THE END OF THE ETT. BELIEVING THERE MIGHT BE A PLUG, THE DECISION WAS MADE TO REINTUBATE THE PATIENT. UPON REINTUBATION, FOUND THE SAME ISSUE. RT THEN INVESTIGATED OTHER UNOPENED 2.5MM ETT IN STOCK AND FOUND THE TIP OF THE ONES FROM LOT #01B1000464 TO BE NARROWED AND THUS CREATING FEELING OF RESISTANCE WHEN SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN PED-SOFT UNCUFFED ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL HUDSON RCI * 01B1000464

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA