BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN DRAIN

    MDR report key: 6574377 · Received May 17, 2017

    Report

    Report Number
    1219977-2017-00073
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    December 21, 2016
    Report Date
    May 17, 2017
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862100013
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DETAILS OF THE COMPLAINT DID NOT PROVIDE IMAGES OF THE ACTUAL CHEST DRAIN IN QUESTION. THE OCEAN CHEST DRAINAGE SYSTEMS HAVE A FEW DIFFERENT CATALOGUE ORDER NUMBERS THAT CONTAIN THE IN-LINE CONNECTOR (ILC) AND A FEW CATALOGUE NUMBERS THAT DO NOT CONTAIN THE ILC. BASED ON THE COMPLAINT DETAILS PROVIDED IT IS NOT CLEAR IF THE CLINICIAN HAD A 2002-000 OR ONE OF THE OTHER OCEAN CHEST DRAINS. THE PHOTO THAT WAS PROVIDED OF THE PACKAGING IS FROM A 2002-000 OCEAN DRAIN WHICH WOULD CONTAIN THE ILC. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO CLARIFY THE ISSUE WITHOUT ANY SUCCESS. A FULL REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT THIS PRODUCTION LOT OF OCEAN CHEST DRAINS PASSED ALL IN-PROCESS AND FINAL QUALITY INSPECTIONS. THE LIKELIHOOD OF A DRAIN BEING CREATED WITHOUT THE ILC IS EXTREMELY LOW. IT IS MORE LIKELY THAT A PRODUCT SUBSTITUTION DURING THE ORDERING/SHIPPING PROCESS WAS MADE AND THE CLINICIAN RECEIVED AN OCEAN DRAIN OF A DIFFERENT CATALOGUE NUMBER THAT DID NOT HAVE THE ILC.

    Additional Manufacturer Narrative · 1

    CORRECTED- INITIAL REPORT FOR THE "DATE RECEIVED BY MANUFACTURER" & EVENT DATE - UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER INQUIRED IF THE OCEAN PRODUCT LINE HAD BEEN CHANGED BECAUSE THEY HAD A UNIT THAT WAS MISSING THE IN-LINE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355629 OCEAN DRAIN DRAIN, SINGLE W/AC, S KDQ ATRIUM MEDICAL CORPORATION 2002-000 236654 00650862100013

    Patients

    Seq Age Sex Outcome Treatment
    1