BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP LS SEC 34'OL

    MDR report key: 1925818 · Received November 8, 2010

    Report

    Report Number
    9613251-2010-00147
    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

    ONE USED DEVICE WAS EVALUATED. TESTING FOUND THE TUBING HAD SEPARATED FROM THE OPTION-LOK MALE ADAPTER. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. MANUFACTURING PERSONNEL AT THE MANUFACTURING FACILITY WILL BE INFORMED OF THE CORRECT SOLVENT APPLICATION METHOD DURING THE MANUFACTURING PROCESS. THIS REPORT REPRESENTS ALL THE INFORMATION 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 PATIENT USE WHILE PRIMING THE TUBING SET WITH AN UNSPECIFIED CONCENTRATION OF METRONIDAZOLE, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE OPTION-LOK MALE ADAPTER. THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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