BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER TEE

    MDR report key: 871403 · Received September 27, 2006

    Report

    Report Number
    3004365956-2006-00010
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 27, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL STAFF WAS UNABLE TO PROVIDE A PRODUCT CODE AND/OR LOT CODE INFORMATION TO VERIFY IF THE PRODUCT IS MANUFACTURED BY TELEFLEX MEDICAL. THE CUSTOMER DID STATE AN UNCERTAINTY WHETHER THE PRODUCT WAS A BRAND MANUFACTURED BY TELEFLEX MEDICAL.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2006, AN INCIDENT OCCURRED INVOLVING A CRACKED/BROKEN GREEN NEBULIZER TEE. HOSPITAL ALLEGES THAT THE ADAPTER BROKE INTO PIECES DURING USE AND WENT INTO ET TUBE. THE PIECES DID NOT ENTER THE PATIENT AND NO INJURY WAS REPORTED. A CT SCAN WAS PERFORMED TO VERIFY NO PIECES WERE INSIDE THE PATIENT. CUSTOMER DOES NOT KNOW WHY/HOW THE TEE BROKE/CRACKED. THE CATALOG NUMBER IS UNKNOWN. CUSTOMER IS NOT CERTAIN THAT THEY USE TELEFLEX MEDICAL-HUDSON NEBULIZER TEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZER TEE NEBULIZER TEE ADAPTER CAF TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention