BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN (48/CASE)

    MDR report key: 3963322 · Received June 19, 2014

    Report

    Report Number
    9615050-2014-04075
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, PARTICULATE WAS NOTED IN AN UNSPECIFIED LOCATION OF THE TUBING SET. THE CUSTOMER CONTACT INDICATED THAT THE PARTICULATE MAY BE A DOT ON THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359424 DC PLUM W/SEC CONVPN (48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA 334815H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA