BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 1941019 · Received December 8, 2010

    Report

    Report Number
    1820334-2010-00657
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 18, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INSPECTED DURING THE MFG PROCESS AND PRIOR TO SHIPPING. PER A CHANGE REQUEST, A NEW FLARE IRON TIP WITH STOP WAS ADDED TO MINIMIZE FLARE SIZE VARIATION IN THE MFG PROCESS. A CHANGE REQUEST WAS ALSO IMPLEMENTED, MAKING AN INJECTION MOLDED VERSION OF THIS PRODUCT (-IMH SUFFIX) AVAILABLE FOR MFG. APPROPRIATE DESIGN CONTROL ACTIVITIES HAVE BEEN COMPLETED. THE ROOT CAUSE OF THE SEPARATION IS UNK. UNFORTUNATELY, NO PRODUCT WAS RETURNED TO ASSIST WITH THE INVESTIGATION. IT IS POSSIBLE THAT THE CATHETER WAS EXPOSED TO FORCES ABOVE WHAT WOULD BE EXPECTED UNDER TYPICAL CIRCUMSTANCES. THE CATHETER WAS CONFIRMED TO BE MANUFACTURED BEFORE THE MORE RECENT CHANGE REQUESTS ADDING TORQUE DRIVERS AND MAKING AN IMH VERSION AVAILABLE. ADDITIONALLY, RECENT TENSILE TESTING OF SIMILAR DEVICES DEMONSTRATED THAT THE CATHETERS MET ALL FORCE AT BREAK REQUIREMENTS AS SPECIFIED IN BS EN 1617:1997. ALTHOUGH NOT AN OUTPUT OF THIS INVESTIGATION, AN ENGINEERING PROJECT WAS INITIATED TO CHANGE THE MFG PROCESS FROM A FLARE INSIDE A CAP AND ADAPTER TO AN INJECTOR MOLDED HUB. PROJECT COMPLETION WAS AUGUST 2010. ADDITIONALLY, TORQUE DRIVERS WERE IMPLEMENTED FOR THE 8.5 FR AND 10.2 FR CATHETERS IN AUGUST AS WELL. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    HUB BECOMES UNATTACHED. A NEW CATHETER WAS PLACED IN THE PT; HOWEVER, NO HARM TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET KDQ BOTTLE, COLLECTION, VACUUM DQY COOK, INC. NA 2515618

    Patients

    Seq Age Sex Outcome Treatment
    1