BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 3904974 · Received June 5, 2014

    Report

    Report Number
    9616066-2014-00590
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K960280
    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). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED SLICE AND LEAK BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE UNCLAMPING THE SLIDE CLAMP THE TUBING WAS SLICED AND BLOOD LEAKED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330274 EXTENSION SET EXTENSION SET, 4-WAY STOPCOCK FPA CAREFUSION CORP 10108964 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK