BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-VAC GUARDIAN RIGID SUCTION CANISTER SYSTEM

    MDR report key: 5503473 · Received March 16, 2016

    Report

    Report Number
    5503473
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 7, 2016
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITHIN THE PAST WEEK WE HAVE HAD SUCTION CANISTERS TO SPONTANEOUSLY CRACK AT THE TOP OF THE CANISTER. THIS HAS OCCURRED IN MULTIPLE PATIENT ROOMS. WE HAVE HAD ABOUT SIX DO THIS SO FAR AND WE ARE SENDING TWO TO MATERIALS MANAGEMENT TO BE INSPECTED FOR PRODUCT DEFECT. THE CANISTERS THAT HAVE CRACKED HAVE BEEN NOTED TO BE HOOKED TO CONTINUOUS HIGH WALL SUCTION ON TWO DIFFERENT TYPES OF SUCTION GAUGES. WHEN THE CANISTERS CRACK WE LOSE SUCTION (NOT ALL, BUT MOST). THIS CAN CAUSE AN ISSUE IF A PATIENT HAS A CHEST TUBE HOOKED TO WALL SUCTION OR IF THE PATIENT NEEDS EMERGENT AIRWAY CLEARING VIA SUCTIONING AND THERE IS NOT APPROPRIATE SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161866 MEDI-VAC GUARDIAN RIGID SUCTION CANISTER SYSTEM VACUUM POWERED BODY FLUID COLLECTION KIT OJR CARDINAL HEALTH 200, LLC 1200 CC RIGID CANISTER

    Patients

    Seq Age Sex Outcome Treatment
    1