BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2629667 · Received June 20, 2012

    Report

    Report Number
    9616066-2012-00419
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 30, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REC'D AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE EXTENSION SET IS LEAKING AT THE AREA OF THE DIAL ON THE SET. SOLUTION INFUSING WAS NORMAL SALINE AND IT WAS RUNNING AT 100ML/HR. THERE WAS NO REPORT OF PT OR USER HARM AND NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

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