BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN DRAIN, SINGLE W/AC, S

    MDR report key: 6168591 · Received December 12, 2016

    Report

    Report Number
    1219977-2016-00254
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862100013
    PMA / PMN Number
    K043582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2002-400 CHEST DRAIN UNIT IS PROVIDED WITH A PRE-FILLED STERILE WATER AMPOULE THAT IS TO BE USED FOR FILLING THE WATER SEAL. CONFUSION AROSE SINCE THIS PARTICULAR DRAIN MODEL WAS NEW TO THEM; THE 2002-000 WITH PRE-ATTACHED FUNNEL FOR FILLING THE WATER SEAL IS THE DRAIN THEY HAVE THE GREATEST FAMILIARITY WITH. BOTH DRAINS (2002-000 AND 2002-400) UTILIZE THE SUCTION PORT FOR FILLING OF THE WATER SEAL. THE INSTRUCTIONS FOR USE CLEARLY INDICATE THAT THE WATER SHOULD BE INSERTED INTO THE SUCTION PORT VIA THE AMPOULE: "FOR MODELS AVAILABLE WITH STERILE FLUID, TWIST TOP OFF BOTTLE AND INSERT TIP INTO SUCTION PORT. SQUEEZE CONTENTS INTO WATER SEAL UNTIL FLUID REACHES 2 CM FILL LINE." THE INFORMATION PROVIDED WITH THE OCEAN CHEST DRAIN IS SUFFICIENT FOR EXPLAINING THE PROPER SET-UP OF THE DRAIN. THE SET-UP SECTION OF THE IFU CLEARLY DESCRIBES THE EXACT STEPS FOR FILLING THE WATER SEAL, INCLUDING WHICH PORT THE WATER SHOULD BE PLACED IN.

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORT RECEIVED STATED THAT THE HOSPITAL HAD AN OCEAN DRAIN THAT THE WATER WAS PUT INTO THE SUCTION CONTROL CHAMBER AND NOT INTO WATER SEAL CHAMBER RESULTING IN THE DRAIN NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819163 OCEAN DRAIN, SINGLE W/AC, S OCEAN DRAIN, SINGLE W/AC, S KDQ ATRIUM MEDICAL CORPORATION 2002-400 00650862100013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention