BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDERITE ENDOTRACHEAL TUBE

    MDR report key: 2195558 · Received May 24, 2011

    Report

    Report Number
    3022472-2011-00001
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    VERATHON INCORPORATED
    Product Code
    BTR
    PMA / PMN Number
    K100564
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT FROM THE MFR/DISTRIBUTOR OF THE GLIDERITE ENDOTRACHEAL TUBES. THE PT IN QUESTION DID NOT DIE FROM A RESULT OF THE USE OF THE ENDOTRACHEAL TUBE, RATHER THE PT DIED FROM SEPTIC SHOCK AFFILIATED WITH MULTIPLE HEALTH ISSUES.

    Description of Event or Problem · 1

    MONDAY, (B)(6) AN INCIDENT OCCURRED WITH A PT, AT (B)(6), WHOM HAD BEEN INTUBATED WITH A GLIDERITE TUBE. THE STAFF WAS CONCERNED THAT THE TUBE/PT WAS EXPERIENCING A DECREASE IN PRESSURE, SO AN IN LINE SUCTION CATHETER (KIMBERLY CLARK "BALLARD" TYPE) WAS USED, IN CONJUNCTION WITH A GLIDERITE ENDOTRACHEAL TUBE, IN AN ATTEMPT TO CLEAN OUT ANY POSSIBLE OBSTRUCTION WITHIN THE TUBE OR WITHIN THE PT'S AIRWAY. IN LESS THAN AN HOUR, THE PT HAD DECEASED. UPON SPEAKING WITH MR. (B)(6) (HOSP RISK MGMT OFFICER), IT WAS DETERMINED THAT THE PT HAD DIED FROM SEPTIC SHOCK. HE WAS UNABLE TO GIVE SPECIFICS LOT NUMBER OF THE TUBE, HOWEVER, HE DID STATE THAT IT WAS A 7.5 MM. VERATHON INC'S GLIDERITE ENDOTRACHEAL TUBE WAS NOT INDICATED AS THE CAUSE OF DEATH, IT WAS MERELY PRESENT DURING A ROUTINE MEDICAL PROCEDURE PRIOR TO THE PT'S DEATH. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDERITE ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR VERATHON INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death