BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HCH ASSEMBLY AQUA+ 2FH

    MDR report key: 1860237 · Received September 22, 2010

    Report

    Report Number
    8040412-2010-00061
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CONNECTING PART OF AQUA+ CRACKED AFTER IT WAS CONNECTED TO THE ET TUBE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HCH ASSEMBLY AQUA+ 2FH AQUA+ BZO TELEFLEX MEDICAL NA 200931

    Patients

    Seq Age Sex Outcome Treatment
    1