BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLD Y-TYPE 105 OL NV

    MDR report key: 2550839 · Received April 23, 2012

    Report

    Report Number
    9615050-2012-00480
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 28, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    KDC
    PMA / PMN Number
    K780880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED BLOOD PRODUCT. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET WITH NORMAL SALINE, THE TUBING SEPARATED AT AN UNSPECIFIED LOCATION FROM THE CYLINDER OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLD Y-TYPE 105 OL NV 79KDC KDC HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA