BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2524816 · Received March 28, 2012

    Report

    Report Number
    9616066-2012-00224
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Report Date
    February 27, 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). CUSTOMER STATES THAT PRODUCT WILL NOT BE RETURNED BECAUSE NO SETS HAVE BEEN SAVED. AN INVESTIGATION COULD NOT BE PERFORMED. THE CAUSE OF REPORTED PROBLEM IS UNK. (B)(4).

    Description of Event or Problem · 1

    END USER REPORTED THAT OVER THE LAST 6 WEEKS, DAILY THEY HAVE ONE OF THE DIAL-A-FLOW SETS LEAK AT THE CENTER OF THE DIAL-A-FLOW WHERE THE TWO SECTIONS MEET AND ROTATE. THE LEAKING IS NOT NOTICED ON PRIMING. IT IS NOTICED WHILE INFUSING ON A PT. NO SETS HAVE BEEN SAVE TO DATE. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. 43000E 1110059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK