BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI TRACHEOSTOMY CARE KIT

    MDR report key: 2973477 · Received February 15, 2013

    Report

    Report Number
    1417592-2013-00008
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 31, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HUSBAND WAS PERFORMING ROUTINE TRACH CARE ON HIS WIFE. IT WAS REPORTED THAT THE WIFE EITHER COUGHED OR INHALED AND THE WET COTTON TIP CAME OFF THE SWABSTICK AND ENTERED HER TRACH. THEY WERE UNABLE TO RETRIEVE THE COTTON TIP. SHE SUBSEQUENTLY DIED. WE HAVE NO OTHER DETAILS PERTAINING THE INCIDENT. THERE IS NO INFORMATION REGARDING HOW THE TRACH CARE WAS BEING PERFORMED OR WHAT PRODUCTS/DEVICES WERE BEING USED. THE OVERALL HEALTH CONDITION OF THE WOMAN OR PRESENCE OF ANY CO-MORBIDITY PRIOR TO THE INCIDENT IS NOT KNOWN. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. UNUSED KITS FROM THE SAME CASE WERE RETURNED AND EVALUATED. THE COTTON WAS FOUND TO BE SECURE ON EACH OF THE STICKS AND REMAINED SECURE EVEN AFTER BECOMING WET. WE HAVE NOT HAD A SIMILAR INCIDENT REPORTED TO US. A ROOT CAUSED HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUSBAND WAS PERFORMING TRACH CARE ON HIS WIFE. THE COTTON TIP APPARENTLY CAME OFF THE SWABSTICK AND ENTERED THE TRACH. THEY WERE NOT ABLE TO RETRIEVE IT AND SHE SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69407 MINI TRACHEOSTOMY CARE KIT BSY MEDLINE INDUSTRIES, INC. 12IY0068

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death