BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVPRM PB CLV OL100IN

    MDR report key: 1915437 · Received November 4, 2010

    Report

    Report Number
    9613251-2010-00146
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 5, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED FOR DELIVERY OF AN UNSPECIFIED VOLUME OF A "STANDARD IV SOLUTION". IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, THE TUBING SEPARATED FROM AN UNSPECIFIED LOCATION. THE TUBING SET WAS REPLACED. THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVPRM PB CLV OL100IN 80FPA FPA HOSPIRA LTD. NA UNK 4W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA