BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK W/ADAPTOR, INTL.

    MDR report key: 2201559 · Received August 3, 2011

    Report

    Report Number
    1417411-2011-00082
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 26, 2011
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PACKAGE CONTAINING THE ENCLOSED HUMIDIFIER ADAPTOR IS NOT SEALED. THE REPORTED DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK W/ADAPTOR, INTL. AQUAPAK NEBULIZER CAF TELEFLEX NA 721107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA