BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRINARY TUBING SET WITH 2 CLAVES

    MDR report key: 1180847 · Received September 23, 2008

    Report

    Report Number
    9613251-2008-00346
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 BACKFLOW OF SOLUTION. THE PRIMARY TUBING SET AND THE SECONDARY TUBING SET WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, BACKFLOW OF SOLUTIONS WAS NOTED FROM THE PRIMARY CONTAINER INTO THE SECONDARY LINE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRINARY TUBING SET WITH 2 CLAVES 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT LIFESHIELD SECONDARY SET