BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP LS TWN 2CLVE

    MDR report key: 2913395 · Received January 9, 2013

    Report

    Report Number
    9613251-2013-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM AN UNSPECIFIED LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 DISCONNECTION. THE OPTION-LOK MALE ADAPTER OF THE EXTENSION TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF AN UNSPECIFIED DEVICE AND WAS BEING USED TO DELIVER AN UNSPECIFIED DEVICE AND WAS BEING USE TO DELIVER AN UNSPECIFIED MEDICATION. THE CUSTOMER CONTACT REPORTED, "THIS WEEKEND IN THE ER DEPT WE HAD AN EXTENSION TUBING WHICH WOULD NOT STAY ATTACHED TO THE SALINE LOCK. DIDN'T SAVE THE FAULTY TUBING, HAD TO GET MEDS IN THE PT STAT." NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE EXTENSION TUBING SET WAS REPLACED AND THE THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12830 NDEHP LS TWN 2CLVE 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK