BEUDAMED
    FDA Adverse Event Summary report: N

    OASIS DRY SUCTION WATER SEAL CHEST DRAIN

    MDR report key: 1930149 · Received December 7, 2010

    Report

    Report Number
    1930149
    Date Received
    December 7, 2010
    Date of Event
    April 20, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A VIGOROUS AIR LEAK WAS FOUND IN A CHEST TUBE DUE TO STAFF USING THE PLASTIC CHEST TUBE CLAMPS ON THE PRODUCT. THE PRODUCT DOES NOT COME WITH CLAMPS THAT ARE COMPATIBLE/SAFE TO USE WITH ITS TUBING. CLAMPING CHEST TUBES IS A COMMON PROCEDURE. THE STAFF SUGGESTED THE MANUFACTURER SHOULD SUPPLY THIS IN THEIR KIT RATHER THAN ALLOWING HEALTHCARE WORKERS TO USE WHATEVER DEVICES THEY HAVE ON HAND. ANOTHER SUGGESTION WAS TO PUT A LARGE WARNING ON THE PACKAGE LABEL WARNING USERS TO ONLY USE A SPECIFIC TYPE OF CLAMP WITH THEIR PRODUCT. THE HOSPITAL PURCHASED METAL CLAMPS WITH A SURFACE THAT DOES NOT DESTROY THE INTEGRITY OF THE CHEST TUBING IN ORDER TO PREVENT FUTURE SIMILAR EVENTS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE STAFF WAS UNAWARE THAT A SPECIFIC TYPE OF CLAMP IS NEEDED WITH THIS PRODUCT. THE CLAMPS USED MADE A HOLE IN THE CHEST TUBE AND CONSEQUENTLY AN AIR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS DRY SUCTION WATER SEAL CHEST DRAIN CHEST TUBE AND DRAINAGE COLLECTION CONTAINER KDQ ATRIUM MEDICAL CORPORATION REF # 3650-100 10636443

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR