BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SWIVEL ADAPTOR PEEP

    MDR report key: 44925 · Received September 6, 1996

    Report

    Report Number
    44925
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    August 25, 1996
    Report Date
    September 6, 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

    BLUE ADAPTORS FROM VENT TUBING TO TRACH OR ET TUBE HAVE CHANGED. THE END BUTTON IS NOW ONLY 1/4" DIAMETER AND DOES NOT SNAP ON LIKE THE 1/2" ONE FROM THE EARLIER MODEL DOES. THE DEVICE POPS OPEN FREQUENTLY AND CAUSES THE LOSS OF VOLUME AND BODY FLUID EXPOSURE TO EMPLOYEES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention