BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN DRAIN

    MDR report key: 10282457 · Received July 16, 2020

    Report

    Report Number
    3011175548-2020-00925
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862102017
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4 AND H6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE IMAGES PROVIDED SHOW THAT THERE IS A KINK IN THE TUBING ON THE PATIENT LINE AS DESCRIBED IN THE COMPLAINT DETAILS. THE KINK IN THE TUBING ALTHOUGH UNDESIRABLE COSMETICALLY STILL MEETS THE FLOW REQUIREMENTS AS STATED IN THE PRODUCT PERFORMANCE SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE LOT OF DRAINS MET THE QUALITY AND PERFORMANCE REQUIREMENTS PRIOR TO RELEASE. IN AN EFFORT TO ENHANCE THE CLINICIAN EXPERIENCE AND REDUCE WASTE, ATRIUM MEDICAL CORPORATION INTRODUCED ENHANCEMENTS TO THE ATRIUM CHEST DRAIN FAMILY THAT SIMPLIFY PACKAGING AND ROUTINE SET-UP OF ATRIUM CHEST DRAINS. THESE ENHANCEMENTS FACTORED-IN CLINICIAN WORKFLOW EXHIBIT MULTIPLE BENEFITS, SUCH AS REDUCING COSTS ASSOCIATED WITH MEDICAL WASTE IN THE HOSPITAL AS WELL AS REDUCING MANUFACTURING CARBON FOOTPRINT. AS PART OF THIS INITIATIVE, THE WALL THICKNESS OF THE PATIENT TUBE SET WAS MODIFIED FROM .094+/- .012 INCHES FOR THE 3/8 INCH TUBING AND .094 +/- 0.16 INCHES ON THE 1/4 IN TUBING TO A MINIMUM SPECIFICATION OF.088 +/-.006 INCHES. THE DIMENSIONAL CHANGES WERE STILL WITHIN THE ORIGINAL PRODUCT REQUIREMENTS. LETTERS OF THESE CHANGES WERE SENT OUT TO THE CUSTOMERS AND DISTRIBUTERS IN FEBRUARY 2019. IN AN EFFORT TO ENSURE THE PRODUCT WAS STILL PERFORMING PROPERLY, A PLANNED ENGINEERING STUDY THAT HAD BEEN CONDUCTED PRIOR TO THIS COMPLAINT INVESTIGATION IN MARCH 2020 (DD019971 DRAINS KINKING EVALUATION) WAS CONDUCTED USING 59 SAMPLES FROM INVENTORY THAT WERE STERILIZED 3X TIMES. THIS STUDY WAS CREATED TO ENSURE THE THRESHOLD FOR AIRFLOW GOING THROUGH THE TUBE SET DID NOT DROP BELOW THE REQUIRED 7.5SLPM AFTER APPLYING A 150 GRAM WEIGHT TO THE TUBE SET. THE RESULT WAS THAT THE LOWEST VALUE RECORDED WAS 24.85SLPM. THIS IS MUCH HIGHER THAN THE THRESHOLD VALUE. ALTHOUGH THE KINK IN THE TUBING IS UNDESIRABLE THE FLOW IS VERY MUCH STILL WITHIN THE 7.5 SLPM REQUIREMENTS. BASED ON THE RESULTS OF THE INVESTIGATION THE KINK IN THE TUBING STILL MEETS THE PRODUCT REQUIREMENT FOR FLOW AS DETERMINED IN THE PLANNED ENGINEERING STUDY. DUE TO THE FEEDBACK FROM THE CUSTOMERS, A DESIGN CONTROL QUALITY PLAN HAS BEEN INITIATED TO REVERSE THE CHANGE THAT CALLED FOR THE WALL THICKNESS REDUCTION.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751329 OCEAN DRAIN BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 2020-000 454828 00650862102017

    Patients

    Seq Age Sex Outcome Treatment
    1