BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUBE, ENDOTRACHEAL HVLP CUFF M

    MDR report key: 1943010 · Received December 21, 2010

    Report

    Report Number
    1417592-2010-00075
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    October 23, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT INVOLVED A (B)(6) FEMALE WHO HAD BEEN INTUBATED ON (B)(6) 2010. ON (B)(6) 2010, THE PILOT BALLOON OF THE ET TUBE WAS FOUND TO BE LAYING ON THE PT. THE PT WAS THEN EXTUBATED AND DID WELL. NO INJURY RESULTED. THERE WAS NO NEED TO RE-INTUBATE THE PT. A ROOT CAUSE FOR THE INCIDENT WAS NOT IDENTIFIED BY THE FACILITY. THERE WAS NO INFO DESCRIBING THE ENDS OF THE PILOT BALLOON OR ANY INDICATION OF DAMAGE TO THE DEVICE. THE FACILITY HAS USED THE ET TUBES WITHOUT PRIOR INCIDENT. WE HAVE NOT HAD A SIMILAR INCIDENT REPORTED TO US. NO TREND EXISTS. AT THIS TIME, WE HAVE NOT RECEIVED THE SAMPLE BACK FOR EVAL. WE HAVE NOT BEEN ABLE TO CONFIRM THE INCIDENT OR IDENTIFY A POTENTIAL ROOT CAUSE. IF THE SAMPLE IS RETURNED AT A LATER DATE, IT WILL BE EVALUATED. DUE TO THE REPORTED INCIDENT, A MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE PILOT BALLOON OF THE ET TUBE WAS FOUND RESTING ON THE PT'S CHEST. THE PT WAS EXTUBATED AND NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, ENDOTRACHEAL HVLP CUFF M NONE BTR MEDLINE INDUSTRIES, INC. DYND43075 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention