BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORACENTESIS TRAY

    MDR report key: 18186 · Received December 2, 1994

    Report

    Report Number
    MW1004275
    Event Type
    Other
    Date Received
    December 2, 1994
    Date of Event
    November 16, 1994
    Report Date
    November 16, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR UTILIZED THORACENTESIS KIT TWICE ON 11/16/94; FIRST KIT REVEALED A LEAK IN HUB OF 22 G NEEDLE. SECOND KIT (SAME LOT), NEEDLE OR; HOWEVER THERE WAS AN AMBIENT GAS LEAK WITH THE CATHETER/14 G NEEDLE/DRAINAGE TUBING QUESTIONED. COULD NOT FIND LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS TRAY THORACENTESIS TRAY KDQ PHARMASEAL DIV. BAXTER HEALTHCARE CORP. K4E390

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other