BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCAM FOUR WAY STANDARD BORE STOPCOCK WITH

    MDR report key: 1241517 · Received November 20, 2008

    Report

    Report Number
    6000001-2008-00776
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FMG
    PMA / PMN Number
    K840394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE CUSTOMER ORIGINALLY INDICATED THE SAMPLE WAS AVAILABLE AND WAS SENT A SAMPLE RETRIEVAL KIT, THE RISK MGMT DEPT HAS INDICATED THAT THE SAMPLE WILL NOT BE MADE AVAILABLE TO BAXTER.

    Description of Event or Problem · 1

    A BAXTER SALES REP REPORTED THE FOLLOWING IN 2008: THE CUSTOMER REPORTED THAT WHILE USING ONE (1) UNIT OF ELCAM FOUR WAY STANDARD BORE STOPCOCK TO ADMINISTER LEVOPHED TO A PT ONE DAY PRIOR, THE SET CRACKED AND LEAKED. IT IS UNK WHEN THIS IS OCCURRING. DURING A FOLLOW-UP CALL WITH THE FACILITY'S DIRECTOR OF CRITICAL CARE SVCS THE NEXT DAY, SHE STATED THAT IT IS UNK WHERE THE LEAK IS COMING FROM OR IF THE SET IS INDEED CRACKED. THE DIRECTOR INDICATED THAT AN UNK QUANTITY OF LEVOPHED LEAKED. IN ADDITION, AN UNK AMOUNT OF BLOOD BACKED UP ONTO THE PT'S BED, AND THE PT'S BLOOD PRESSURE DROPPED. THE PT THEN WOKE UP AND WAS AGITATED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELCAM FOUR WAY STANDARD BORE STOPCOCK WITH 80FMG FMG BAXTER HEALTHCARE UR08E08046

    Patients

    Seq Age Sex Outcome Treatment
    1