BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN WATER SEAL CHEST DRAIN

    MDR report key: 1132824 · Received August 21, 2008

    Report

    Report Number
    MW5008062
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 27, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHEST DRAIN TUBES BECAME DISCONNECTED FROM "Y" CONNECTOR WHEN PT FELL. DRAINAGE TUBE CLIPS/CLAMP SLIPPED OFF OF CONNECTOR. RIDGES ON "Y" CONNECTOR NOT THICK ENOUGH TO HOLD CLIP/CLAMP. CHEST DRAIN USED IN CONJUNCTION WITH NOVOSCI CONN, EQUAL WYE 3/8. "Y" CONNECTOR USED ON CONJUNCTION WITH ATRIUM OCEAN WATER SEAL CHEST DRAIN. SECOND DEVICE: DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: POST CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCEAN WATER SEAL CHEST DRAIN CHEST DRAIN KDQ ATRIUM MEDICAL CORP 10373557
    2 CONN, EQUAL WYE 3/8 DTL NOVOSCI 289175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention