BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 3050438 · Received April 8, 2013

    Report

    Report Number
    9613251-2013-00098
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 15, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K113683
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 SEPARATION. ON AN UNSPECIFIED DATE, THE OPTION-LOK MALE ADAPTER OF A PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SET AND WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SETS PRIOR TO PT USE, THE TUBING SEPARATED FROM AN UNSPECIFIED LOCATION FROM THE FILTER OF THE EXTENSION TUBING SET AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE EXTENSION TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144220 NDHP 0.2 MICRN HP CL 80FPA FPA HOSPIRA LTD. NA 221074W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA