BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 22104450 · Received May 29, 2025

    Report

    Report Number
    3011175548-2025-000004
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Report Date
    July 9, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862110012
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION: H6. RELATED MDR: 3011175548-2025-0000049. THIS COMPLAINT WAS RECEIVED ALONGSIDE (B)(4), BOTH ASKING THE SAME QUESTION. THE USER ASKED IF IT IS OK TO CUT THE PATIENT HOSE (OF OASIS DRAINS) WITH SCISSORS IN ORDER TO ATACH IT TO A DIFFERENT CONNECTOR. THE REPORT STATES THAT "DUE TO ATRIUM CATHETERS ARE NOT AVAILABLE ANYMORE, CUSTOMERS USE DIFFERENT SOLUTIONS FROM DIFFERENT MANUFACTURES/DISTRIBUTORS. BUT REGARDING ONGOING MDR REGULATIONS CUSTOMERS ASK ABOUT STATEMENT FOR OASIS (3600-100 AND 3612-100) THAT CLARIFYING HOW OTHER THORAX CATHETERS CAN/SHOULD BE CONNECTED TO DEVICE." IT ALSO STATES THAT OASIS DRAINS ARE SUPPLIED WITH 3/8X3/8 [CONNECTORS] AND THAT IT "SOMETIMES DOESN'T FIT CATHETER, EVEN IF IT IS >24FR." THEY STATE THAT THEY WANT A SOLUTION BECAUSE ATRIUM NO LONGER SELLS CATHETERS AND CONNECTORS. IT IS NOT RECOMMENDED BY GETINGE TO CUT THE PATIENT LINE. IF THE USER WANTS TO USE A DIFFERENT CONNECTOR, THE BARBED CONNECTOR CAN BE PULLED OFF THE PATIENT LINE. GETINGE OFFERS BOTH CATHETERS AND CONNECTORS IN A VARIETY OF SIZES (ALTHOUGH THE CONNECTORS ARE ONLY SOLD IN THE UNITED STATES AND ARE NOT AVAILABLE IN SWEDEN), INCLUDING SOME THAT TRANSITION BETWEEN LARGER AND SMALLER SIZES. THE SMALLEST SIZE CATHETER AN OASIS SINGLE DRAIN CAN ATTACH TO IS 24 FR AND THAT SIZE CAN ONLY FIT OVER THE FIRST BARB OF THE CONNECTOR. IT IS INTENDED TO BE A TIGHT FIT AND TYPICALLY REQUIRES THE CATHETER TO STRETCH A LITTLE TO PULL OVER THE STEPS OF THE CONNECTOR. IF THE USER ATTEMPTED TO PUSH THE CATHETER FURTHER UP THE CONNECTOR THAN THE STEPS ALLOW, FOR INSTANCE TO MATCH THE APPEARANCE OF THE PATIENT HOSE CONNECTION, IT WOULD CERTAINLY BE CHALLENGING TO DO SO. A DHR REVIEW COULD NOT BE COMPLETED BECAUSE NO LOT NUMBER WAS PROVIDED. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THIS COMPLAINT IS RELATED TO DESIGN, MANUFACTURING OR INSTRUCTIONS FOR USE. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR SETUP AND USE OF THE DEVICE. IT DOES NOT SPECIFICALLY SAY NOT TO CUT THE PATIENT TUBE, BUT ALSO DOES NOT INSTRUCT THE USER TO DO SO IN ORDER TO REMOVE THE CONNECTOR. THE BARBED CONNECTOR IS INTENDED TO CONNECT AND DISCONNECT FROM CATHETERS, SO IT SHOULD BE UNDERSTOOD THAT IT CAN DO THE SAME WITH THE PATIENT TUBE. COMPLAINT TRENDING FOUND THAT THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL. NO EXCURSIONS WERE IDENTIFIED. A COMPLAINT HISTORY REVIEW WAS COMPLETED WHICH FOUND NO SIMILAR COMPLAINTS TO THIS ONE OTHER THAN (B)(4). A RECURRING LOT NUMBER REPORT COULD NOT BE COMPLETED BECAUSE NO LOT NUMBER WAS PROVIDED. THE COMPLAINT SEEMS TO BE A MATTER OF PREFERENCE, AS THE USER IS UNSATISFIED BY THE SELECTION OF PRODUCTS AVAILABLE. THEY DID SUGGEST THAT THERE MAY BE AN ISSUE WITH THE FIT OF THE CONNECTORS, BUT DID NOT PROVIDE A LOT NUMBER WITH WHICH TO EVALUATE THE MANUFACTURING HISTORY. IT IS ALSO NOT KNOWN WHEN THE DRAIN WAS MANUFACTURED SO A CONTEMPORANEOUS DEVICE CANNOT BE EVALUATED EITHER. THE DRAIN IN QUESTION WAS NOT RETURNED FOR EVALUATION. A PICTURE WAS INCLUDED IN THE USER'S EMAIL WHICH SHOWS THE BARBED CONNECTOR OF AN OASIS DRAIN. NOTHING APPEARS OBVIOUSLY WRONG WITH IT AND NOT MUCH ELSE CAN BE GLEANED FROM THE PHOTOGRAPH. IF THERE WERE A SYSTEMIC ISSUE WITH THE FIT OF OASIS CONNECTORS, MANY COMPLAINTS WOULD BE EXPECTED. A COMPLAINT HISTORY REVIEW FOUND NO OTHER COMPLAINTS BUT THIS ONE AND (B)(4) FROM THE SAME CUSTOMER. AS SUCH, THE COMPLAINT IS CONFIRMED. NO DEVICE NONCONFORMANCE IS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THIS COMPLAINT IS USER - USER PREFERENCE.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    RECEIVED GENERAL INFORMATION FROM GETINGE SALES REGARDING QUESTIONS AND CONCERNS FROM NORDIC CUSTOMERS REGARDING COMPATIBILITY AND INSTRUCTIONS FOR CONNECTING ATRIUM OASIS CHEST DRAINS WITH NON-ATRIUM CATHETERS, DUE TO NON-AVAILABILITY OF ATRIUM CATHETERS. FEEDBACK STATES THAT BECAUSE OASIS IS SUPPLIED WITH 3/8 X 3/8 AS STANDARD IT SOMETIMES DOESN¿T FIT OTHER CATHETERS, EVEN IF IT IS >24FR. SOMETIMES CUSTOMERS NEED TO FIND A CONNECTOR TO UTILIZE BEST FUNCTION. USERS QUESTION WHETHER IT IS OKAY FOR THEM TO CUT THE PATIENT HOSE WITH SCISSORS TO CHANGE THE CONNECTOR AND/OR CATHETER. THIS IS CONTRARY TO EU MDR REGULATIONS, AS IT IS CHANGING/TRANSFORMING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718051 OASIS BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 3600-100 00650862110012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown