BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1001476 · Received February 19, 2008

    Report

    Report Number
    9610849-2008-00004
    Event Type
    Other
    Date Received
    February 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE UNIDENTIFIED: ROOT CAUSE CANNOT BE DETERMINED SINCE SAMPLE IS NOT AVAILABLE. INVESTIGATION: A DATA SEARCH REVEALED NO OTHER COMPLAINTS FOR LOT# 7082101. CONCLUSIONS: DEFECT WAS NOT CONFIRMED SINCE IT COULD NOT BE DUPLICATED. FUNCTIONAL AND VISUAL EVALUATIONS WERE NOT PERFORMED SINCE NO SAMPLE WAS REC'D FOR EVAL. DURING THE MFG OF THIS LOT IT WAS APPLIED A PRESSURE TEST AT 1300 PSI WHICH IS GREATER THAN THE PRESSURE USED 75-1200 PSI BY THE CUSTOMER. PRESSURE TEST METHOD WAS FOLLOWED ACCORDING INSTRUCTION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MALE WAS UNDERGOING A CARDIAC CATH PROCEDURE TO RULE OUT CAD. A 5FR CATHETER WAS PLACED IN THE LEFT VENTRICULAR FOR THE LV GRAM PROCEDURE. THE LUER LOCK FROM THE MODEL # 900101 SYRINGE CAME DETACHED DURING THE INJECTION. CUSTOMER REPORTED THAT CONTRAST SQUIRTED ONTO THE FLOOR AND THE LOWER PART OF THE PT DRAPE, NO CONTRAST SPLATTER ON THE STAFF OR PT. THE PROTOCOL USED FOR THE PROCEDURE WAS 10ML/SEC FOR A TOTAL VOLUME OF 30ML AT 1000 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE DXT COVIDIEN 900101 7082101

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR