BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1010239 · Received March 7, 2008

    Report

    Report Number
    MW5005833
    Event Type
    Injury
    Date Received
    March 7, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 2008
    Manufacturer
    TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIVISION
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED WITH A SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE FOR APPROX 8 DAYS. AT THE TIME OF EXTUBATION SEVERE UPPER AIRWAY OBSTRUCTION AND STRIDOR DEVELOPED, NECESSITATING EMERGENCY REINTUBATION. UPON REVIEW WITH THE INTENSIVIST AND NURSE ANESTHETIST PRESENT AT THE TIME OF REINTUBATION, THIS HAS BEEN A NEWLY RECOGNIZED COMPLICATION ASSOCIATED WITH THE RECENT PROCUREMENT OF THIS DEVICE, REPLACING THE PREVIOUSLY EMPLOYED NON-SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBES. IN A NUMBER OF INSTANCES, SIMILAR EMERGENT REINTUBATION WAS REQUIRED, AND IN SELECT CASES TRACHEOSTOMY. THE INFERENCE IS THAT MUCOSAL TRAUMA ATTENDANT TO THE USE OF THE SUCTION RESULTS IN AIRWAY EDEMA AND OBSTRUCTION AT THE TIME THE TUBE IS REMOVED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: IMPAIRED MENTAL STATUS, RESPIRATORY AIRWAY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO EVAC TRACHEAL TUBE BTR TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIVISION CE 0123 070800 1343

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| S