BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH FLOW REGULATOR

    MDR report key: 2568069 · Received May 2, 2012

    Report

    Report Number
    9616066-2012-00333
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Report Date
    April 17, 2012
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A LEAK AROUND THE DIAL COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING AROUND THE DIAL. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH FLOW REGULATOR FPA CHURCHILL MEDICAL SYSTEMS, INC. 43000E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ADMINISTRATION SET: MODEL/LOT UNK