BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDICAP

    MDR report key: 655541 · Received December 22, 2005

    Report

    Report Number
    2936999-2005-00539
    Event Type
    Other
    Date Received
    December 22, 2005
    Date of Event
    December 15, 2005
    Report Date
    December 20, 2005
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IN 2005 AN EMERGENCY INTUBATION WAS DONE ON A PEDIATRIC PATIENT 5 DAYS PRIOR TO REPORT. AFTER THE INTUBATION A PEDICAP CO2 DETECTOR WAS ATTACHED TO THE 15MM CONNECTOR OF THE ETT AND A RESUSCITATION BAG TO THE OTHER SIDE. THE PATIENT WAS VENTILATED AND THE ETT POSITION WAS CONFIRMED. THE THERAPIST REMOVED THE PEDICAP FROM THE ETT AND THEN ATTEMPTED TO SEPARATE THE PEDICAP FROM THE RESUSCITATION BAG. THE MALE CONNECTION PORTION OF THE PEDICAP WAS STUCK IN THE FEMALE CONNECTOR OF THE RESUSCITATION BAG AND COULD NOT BE REMOVED. THE MALE CONNECTION OF THE PEDICAP SNAPPED OFF AND COULD NOT BE REMOVED FROM THE BAG. THE THERAPIST FOUND ANOTHER RESUSCITATION BAG TO USE FOR VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICAP PEDIATRIC END TIBIAL CO2 DETECTOR CCK NELLCOR PURITAN BENNETT, INC. PEDICAP 5287178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other