BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP LS SEC 34'OL

    MDR report key: 1925905 · Received November 8, 2010

    Report

    Report Number
    9613251-2010-00148
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 29, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. PRIOR TO PT USE WHILE PRIMING THE TUBING SET WITH AN UNSPECIFIED ANTIBIOTIC, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE OPTION-LOK MALE ADAPTER. THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP LS SEC 34'OL 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA