BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM MICDRP NITRO OL

    MDR report key: 3231081 · Received July 12, 2013

    Report

    Report Number
    9615050-2013-02019
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. AT AN UNSPECIFIED TIME, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED CONNECTOR OF THE TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323425 PLM MICDRP NITRO OL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 211865H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA