BEUDAMED
    FDA Adverse Event Summary report: N

    OHMEDA MEDICAL

    MDR report key: 5313686 · Received September 24, 2004

    Report

    Report Number
    1121732-2004-00010
    Date Received
    September 24, 2004
    Date of Event
    August 2, 2004
    Report Date
    September 24, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONAL MANUAL STATES THAT: "THIS PRODUCT MUST BE CHECKED PERIODICALLY. A DEFECTIVE PRODUCT SHOULD NOT BE USED. PARTS THAT ARE BROKEN, MISSING, PLAINLY WORN, DISTORTED OR CONTAMINATED SHOULD BE REPLACED IMMEDIATELY. THE PRE-USE CHECKOUT PROCEDURE MUST BE PERFORMED BEFORE USING THIS EQUIPMENT ON EACH PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PIECE OF PLASTIC WAS DISCOVERED INSIDE THE PATIENT TUBE OF AN INTERSURGICAL WATERS CIRCUIT DURING THE PRE-USE CHECKOUT PROCEDURE. ON INVESTIGATION, THIS WAS FOUND TO HAVE COME FROM THE END OF THE PLASTIC FLOWMETER NIPPLE WHICH WAS USED TO TEST THE CIRCUIT BEFORE IT WAS PUT INTO USE. THE CONCLUSION WAS THAT THE NIPPLE WAS PREVIOUSLY DAMAGED BY IMPACT, CAUSING IT TO DETACH DURING TESTING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA MEDICAL OXYGEN TUBING NIPPLE BYX OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK