BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN PRESSURE MONITORING SET

    MDR report key: 1832650 · Received September 8, 2010

    Report

    Report Number
    1820334-2010-00430
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 9, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED. THERE IS 100% VERIFICATION THAT THE SURFACE OF THE CATHETER IS FREE OF DAMAGE AND EXCESS BUMPS OR ROUGHNESS AND THAT THE DISTAL TIP/END HOLE DOES NOT HAVE ANY SPLITS, NICKS OR DAMAGE. APPROPRIATE DESIGN CONTROLS ACTIVITIES HAVE BEEN COMPLETED. LABEL CONTAINS GRAPHICAL SYMBOLS REQUIRING STORAGE IN A DARK, DRY AND COOL LOCATION. THE IFU BOOKLET CONTAINS INFO ON PROPER USAGE AND MAINTENANCE. UNFORTUNATELY, NO PRODUCT WAS RETURNED AND LIMITED INFO REGARDING THE CIRCUMSTANCES SURROUNDING THE EVENT WERE PROVIDED. AT THIS TIME, THE ROOT CAUSE OF THE SEPARATION REMAINS UNK. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    THE ARTERIAL LINE WAS NOTED TO NOT BE WORKING AND LEAKING AT THE SITE. WHEN THE LINE WAS REMOVED FROM THE PT, ONLY A SMALL AMOUNT OF THE CATHETER WAS PRESENT. THE PT WAS CRITICALLY ILL AND THE DECISION WAS MADE TO NOT RETRIEVE THE RETAINED PIECE OF CATHETER. THE PTS OUTCOME IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LUMEN PRESSURE MONITORING SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 2503239

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR