BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN SINGLE DRAIN

    MDR report key: 3557953 · Received October 9, 2013

    Report

    Report Number
    1219977-2013-00142
    Event Type
    Malfunction
    Date Received
    October 9, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 13, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IN-LINE CONNECTOR (ILC) ASSEMBLY WAS CUT FROM THE DRAIN FOR EASE IN EVALUATING THE REPORTED ISSUE. UPON EXAMINATION OF THE ILC ASSEMBLY THE SLIDE OR LOCKING MECHANISM APPEARED TO BE SLIGHTLY OFF CENTER AS COMPARED TO A DIFFERENT ILC ASSEMBLY. THE ILC ASSEMBLY IS CONSTRUCTED OF PLASTIC MOLDED COMPONENTS. WHEN THE SLIDE IS ACTIVATED IT PUSHES AGAINST THE SPRING TAB TO ALLOW SEPARATION OF THE TWO HALVES OF THE ILC. THE SPRING TAB WILL RETURN THE SLIDE TO THE LOCKED POSITION. WHEN THE TWO HALVES ARE RECONNECTED, THE SLIDE MOVES AND THE TWO HALVES LOCK IN PLACE. HOWEVER, IF TRIGGER ON THE SLIDE AND THE SPRING FEATURE ARE NOT ALIGNED THE ILC WOULD NOT LOCK THE TWO HALVES TOGETHER. FURTHER ANALYSIS OF THE ILC ASSEMBLY WHEN DISSECTED REVEALED THAT THE SPRING /TAB IS SLIGHTLY BENT AND OFF CENTER TOWARDS THE TOP END. ADDITIONALLY, THE TRIGGER FEATURE ON THE SLIDE IS SLIGHTLY DEFORMED ON THE SAME SIDE. THE DEFORMED SLIDE/SPRING MECHANISM THAT IS RESPONSIBLE FOR LOCKING THE TWO HALVES OF ILC ASSEMBLY WAS THE REASON WHY THE ILC DID NOT LOCK INTO PLACE. DURING THE AUTOMATED MFR PROCESS, EACH ILC ASSEMBLY IS FULLY VERIFIED FOR THE PRESENCE THE SLIDE AND THE FORCE TO INSERT THE SLIDE INTO THE ILC HOUSING. THE FORCE IS MEASURED AND NEEDS TO BE WITHIN A SET RANGE. IN SUMMARY THE AUTOMATED ASSEMBLY EQUIPMENT IS LOOKING FOR THE PRESENCE AND FUNCTIONALITY OF THE SPRING/TAB FEATURE ON THE ILC HOUSING. ADDITIONALLY, EACH ILC ASSEMBLY IS FULLY VERIFIED THROUGH AN AUTOMATED LEAK TEST. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THE EVIDENCE GATHERED DURING THE ANALYSIS OF THE RETURNED ILC ASSEMBLY SHOWS THAT THE LOCKING MECHANISM THAT KEEPS THE TWO HALVES FROM COMING APART WAS NOT FUNCTIONING PROPERLY. AS A RESULT OF THE SPRING TAB BEING OFF CENTER AND THE DEFORMATION ON THE TRIGGER FEATURE OF THE SLIDE, THE ILC ASSEMBLY REMAINED IN THE LOCKED POSITION. IT IS UNKNOWN AS TO HOW THE DEFORMATION ON THE SPRING AND SLIDE FEATURES OCCURRED AND TO DETERMINE THE EXACT CAUSE OF THE EVENT. IT IS ENGINEERING'S CONCLUSION THAT THIS IS AN ISOLATED INCIDENT. BASED ON AN AVERAGE ANNUAL USAGE OF (B)(4) THIS IS THE FIRST REPORTED EVENT FOR THIS ATTRIBUTE, AND A REVIEW OF THE COMPLAINTS FOR THE PAST 5 YEARS WAS CONDUCTED AND THERE HAVE BEEN NO INCIDENTS OR SIMILAR INCIDENTS OF THE DESCRIBED COMPLAINT.

    Description of Event or Problem · 1

    AN OCEAN SINGLE DRAIN WAS BEING USED FOR AN IN SERVICE TRAINING AND AFTER DISCONNECTING THE PT TUBE FROM THE IN-LINE CONNECTOR, THE CONNECTOR WOULD NOT SPRING BACK INTO THE "LOCKED POSITION". THIS MEANS THAT THE TWO HALVES OF THE IN-LINE CONNECTOR ASSEMBLY WOULD NOT LATCH/LOCK TOGETHER UPON RE-CONNECTION DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513714 OCEAN SINGLE DRAIN KDQ ATRIUM MEDICAL CORP. 2002-000 10895208

    Patients

    Seq Age Sex Outcome Treatment
    1