BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

    MDR report key: 3720445 · Received November 27, 2013

    Report

    Report Number
    9615050-2013-05418
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND 510K OF K023062. 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 BACKFLOW. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, AFTER AN UNSPECIFIED TRANSFUSION OF AN UNSPECIFIED SOLUTION, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED LENGTH OF BLOOD BACKFLOWED IN THE TUBING SET AND UNSPECIFIED TUBING SETS. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619563 GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS) UNK FRN HOSPIRA COSTA RICA LTD. NA 281345H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED TUBING SETS, MFR UNK