BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS MICROBR EXT SET

    MDR report key: 1931702 · Received November 22, 2010

    Report

    Report Number
    9613251-2010-00157
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 15, 2010
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, A SEPARATION. DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THAT WHEN THE TUBING WAS "GENTLY PULLED ON", THE TUBING SEPARATED FROM THE T-CONNECTOR. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS MICROBR EXT SET 80FPA FPA HOSPIRA, LTD NA 88211NS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA