BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15 MM X 12 MM ADAPTER

    MDR report key: 558533 · Received December 2, 2004

    Report

    Report Number
    9680866-2004-00001
    Event Type
    Injury
    Date Received
    December 2, 2004
    Date of Event
    November 23, 2004
    Report Date
    December 2, 2004
    Manufacturer
    UNOMEDICAL INC
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN NOVEMBER 2004 AFTER 5:00 PM CUSTOMER SERVICE MANAGER WAS CONTACTED BY PHONE BY A FDA OFFICE IN DALLAS DISTRICT OFFICE REGARDING AN INCIDENT WITH A PATIENT IN HOSPITAL THREE DAYS LATER WAS FULLY AWARE ABOUT THIS INCIDENT WHEN FDA SUPERVISOR CALLED IN TO NOTIFY THAT SEVERAL DAYS AGO THERE WAS AN INCIDENT WITH A PATIENT HOSPITALIZED. AT THAT TIME THE PATIENT WAS UNDER THE CARE OF AN ANESTHESIOLOGY. THE AIRWAY TUBING THAT WAS USED- AIR WAT ADAPTER, AFTER COMPLICATIONS BEGIN IT WAS DISCOVERED THAT THE PLASTIC CONNECTOR WHICH CONNECTED TO RESERVOIR BAG AT THE TEE PIECE WAS OCCLUDED BY A PLASTIC MEMBRANE. SINCE THEN THEY HAD FOUND SEVERAL OF THE PLASTIC DEVICE OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15 MM X 12 MM ADAPTER 15 MM X 22 MM ADAPTER BZA UNOMEDICAL INC 962-E 04-40

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening| R