BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH FLOW REGULATOR

    MDR report key: 2568068 · Received May 2, 2012

    Report

    Report Number
    9616066-2012-00328
    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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2012. (B)(4). THIS REPORT WAS FILED BY THE DISTRIBUTOR: (B)(4). THE PRODUCT HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DIAL-A-FLOW SET LEAKED WHILE IN USE ON A PT. USER HAS NOTICED THAT THE SET APPEARS DIFFERENT FROM HOW IT USED TO LOOK. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT 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 1112087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ADMINISTRATION SET