BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SWIVEL ADAPTOR "PEEP KEEP"

    MDR report key: 44944 · Received September 6, 1996

    Report

    Report Number
    44944
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    August 25, 1996
    Report Date
    September 3, 1996
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEM
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ADAPTOR DEVICE USED BETWEEN VENT TUBING AND ET TUBE OR TRACH TUBE HAS CHANGED FROM 1/2" TO 1/4" AND POPS OPEN FREQUENTLY CAUSING LOSS IN VOLUME AND BODY FLUID EXPOSURE TO EMPLOYEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX SWIVEL ADAPTOR "PEEP KEEP" ADAPTOR BZA SMITHS INDUSTRIES MEDICAL SYSTEM NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention