BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VTD IV MICRODRIP

    MDR report key: 3172392 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01530
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    December 8, 2012
    Report Date
    May 9, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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 PARTICULATE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT AN UNSPECIFIED PARTICULATE WAS NOTED AT AN UNSPECIFIED LOCATION IN THE TUBING OF THE TUBING SET. THERE WAS NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED, IF ANY MEDICAL INTERVENTIONS WERE REQUIRED, AND THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249557 VTD IV MICRODRIP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK