BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LF Y-TP MICBR LSC

    MDR report key: 1358876 · Received February 16, 2009

    Report

    Report Number
    9613251-2009-00024
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 28, 2009
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY THE HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SET WAS ACCESSED WITH AN UNSPECIFIED 10ML SALINE FLUSH SYRINGE. AT THAT TIME, A LEAK WAS NOTED AT THE CONNECTION OF THE "Y" CONNECTOR AND THE DISTAL TUBING. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS REPORTED. THE TUBING SET WAS REPLACED AND THERAPY WAS INITIATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LF Y-TP MICBR LSC 80FPA FPA HOSPIRA, LTD. NA 65053NS

    Patients

    Seq Age Sex Outcome Treatment
    1