BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN (48/CASE)

    MDR report key: 3770066 · Received January 28, 2014

    Report

    Report Number
    9615050-2014-00721
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 2, 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 IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. 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 UNABLE TO PRIME THE TUBING SET. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. DURING PRIMING PRIOR TO PATIENT USE, THE CUSTOMER CONTACT REPORTED THAT THE FLUID CANNOT DRIP DOWN. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60536 DC PLUM W/SEC CONVPN (48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA