BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP LS TWN 2CLVE

    MDR report key: 3832323 · Received February 10, 2014

    Report

    Report Number
    9613251-2014-00022
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AIR IN THE TUBING SET. ON AN UNSPECIFIED DATE, THE MALE ADAPTER OF AN UNSPECIFIED PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SET FOR A DELIVERY OF AN UNSPECIFIED MEDICATION, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED NUMBER OF TINY BUBBLES WERE NOTED IN THE EXTENSION TUBING SET ENTERED THE PATIENT'S IV ACCESS SITE. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87903 NDEHP LS TWN 2CLVE 80FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR BAXTER HEALTHCARE| UNSPECIFIED PRIMARY TUBING SET, LIST #UNK,