BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM NICDRP NITRO OL

    MDR report key: 3023111 · Received February 26, 2013

    Report

    Report Number
    9615050-2013-00278
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 24, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, A TUBING SEPARATED FROM THE OPTION-LOK MALE ADAPTER. THE POSSIBLE CAUSES WERE INADEQUATE SOLVENT APPLICATION OF THE SOLVENT DRIED PRIOR TO INSERTION OF THE TUBING INTO THE OPTION-LOK MALE ADAPTER. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE TUBING WAS FOUND SEPARATED FROM THE OPTION-LOK MALE ADAPTER OF THE TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83140 PLM NICDRP NITRO OL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 041015H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA