BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-SHAPED BLOOD SET W/ PUMP

    MDR report key: 3378657 · Received September 13, 2013

    Report

    Report Number
    9615050-2013-03028
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    BRZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER . THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. 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 PARTICULATE. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME PRIOR TO PRIMING OF THE TUBING SET, IT WAS REPORTED THAT PARTICULATE WAS NOTED IN THE DRIP CHAMBER OF THE TUBING SET. IT WAS REPORTED THAT THE PARTICULATE WAS DESCRIBED AS A SHINY RESIDUE OF AN UNSPECIFIED MATERIAL. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFO 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
    462059 Y-SHAPED BLOOD SET W/ PUMP UNK BRZ HOSPIRA COSTA RICA LTD. NA 231105G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA