BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 3142767 · Received May 24, 2013

    Report

    Report Number
    9613251-2013-00154
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVERY AN UNSPECIFIED MEDICATION. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO PT'S IV ACCESS SITE. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE OPTION-LOK MALE ADAPTER OF THE TUBING SET. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232310 LSLF EXT SET W CLV 80FPA FPA HOSPIRA LTD. NA 23159NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED IV CATHETER, MFR: UNK