BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN (48/CASE)

    MDR report key: 3952748 · Received May 19, 2014

    Report

    Report Number
    9615050-2014-03489
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 23, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, PARTICULATE WAS NOTED INSIDE PRIOR TO PATIENT USE, PARTICULATE WAS NOTED INSIDE 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
    295863 DC PLUM W/SEC CONVPN (48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA 330425H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA