BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1000ML 0.9% SODIUM CHLORIDE INJECTION USP

    MDR report key: 1052109 · Received May 6, 2008

    Report

    Report Number
    1052109
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BAXTER
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    ICU RN'S HAVE REPORTED A 1000ML NS BAG PROPERLY INSERTED INTO PRESSURE BAG FOR ARTERIAL MONITORING. UPON PRESSURIZING, THE BAG OF NS SPRANG A LEAK. IT IS UNKNOWN IF FULL PRESSURIZATION OF 300MMHG WAS REACHED OR NOT. LATER THE SAME DAY A SECOND BAG WAS LEAKING BETWEEN THE TWO PORTS. BAGS ARE FROM 2 DIFFERENT LOT #'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1000ML 0.9% SODIUM CHLORIDE INJECTION USP BAG, IV, SALINE KPE BAXTER * C736934 10/31/2009
    2 UNIFUSOR (STATCORP) PRESSURE INFUSOR KZD CARDINAL HEALTH 1000CC INFUSOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 *