BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYNE PNEUMOTHORAX TRAY

    MDR report key: 1833437 · Received September 8, 2010

    Report

    Report Number
    1820334-2010-00454
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. (B)(4) - NO PATIENT OUTCOME/CONSEQUENCE WAS REPORTED. (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED. QUALITY CONTROL SPECIFICATION REQUIRES 100% CONFIRMATION THAT THE FITTINGS ARE SECURE VIA A MANUAL TUG AND TWIST. AN IFU IS PROVIDED THAT INSTRUCTS THE CLINICIAN TO PERFORM INSPECTIONS OF THE CATHETER AND CONNECTIONS REGULARLY. ADDITIONALLY, THE PHYSICIAN IS INSTRUCTED TO SECURE THE CATHETER IN POSITION BY USING A BIO-OCCLUSIVE DRESSING OR SUTURING IF DESIRED. NEITHER THE COMPLAINT DEVICE NOR LOT NUMBER WERE PROVIDED TO ASSIST WITH THIS INVESTIGATION. WITHOUT A LOT NUMBER, WE ARE UNABLE TO DETERMINE A DATE OF MANUFACTURE FOR THIS PRODUCT AND SUBSEQUENTLY UNABLE TO DETERMINE THE MANUFACTURING METHOD USED DURING HUB ASSEMBLY. IT IS POSSIBLE THE CATHETER WAS SUBJECTED TO FORCES BEYOND THE INTENDED REQUIREMENTS. HOWEVER, WITH THE LIMITED INFORMATION AVAILABLE, THE ROOT CAUSE REMAINS UNKNOWN. WE ARE TAKING MEASURES TO ADDRESS HUB SEPARATIONS AS WELL AS AN ENGINEERING PROJECT HAS BEEN INITIATED TO CONVERT THIS PRODUCT TO AN INSERT MOLDED HUB. IN ADDITION, FLARE STOPS AND TORQUE DRIVERS WERE IMPLEMENTED FOR THIS PRODUCT LINE ON (B)(6) 2010. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    THE CATHETER PULLED APART AT THE HUB JUNCTION ONE HOUR AFTER INSERTION WHEN PATIENT WAS SITTING UP IN CHAIR. THE CATHETER WAS IMMEDIATELY REMOVED AND A NEW CATHETER WAS PLACED ABOVE ORIGINAL SITE. CATHETER WAS ALL IN ONE PIECE MINUS THE HUB JUNCTION. ANOTHER PNEUMOTHORAX CATHETER HAD TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAYNE PNEUMOTHORAX TRAY NONE DQR COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR