BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2801301 · Received October 17, 2012

    Report

    Report Number
    9613251-2012-00206
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 24, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE MALE ADAPTER OF AN UNSPECIFIED PRIMARY TUBING SET WAS CONNECTED TO THE CLAVE PORT OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT SOLUTION LEAKED AT THE CLAVE PORT. THE CUSTOMER CONTACT REPORTED DURING VISUAL INSPECTION, IT WAS NOTED THAT THE TUBING HAD SEPARATED FROM THE CLAVE PORT OF THE EXTENSION TUBING SET. THE EXTENSION TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK