BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP CENTRAL VENOUS OXIMETRY SET

    MDR report key: 3973485 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01759
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PRESEP CATHETER KIT WAS RETURNED FOR EVALUATION IN OPENED ORIGINAL TRAY. THE OUTER BOX WAS NOT RETURNED FOR EVALUATION. SOLIDIFIED POVIDONE IODINE WAS OBSERVED ON ONE OF THE PRESEP BOWLS. ONE LOOSE HAIR-LIKE PARTICULATE WAS OBSERVED ON THE TRAY WHICH THE STOPCOCKS WERE PLACED. ONE END OF THE PARTICULATE APPEARED TO BE CONSISTENT WITH A HAIR FOLLICLE. THE OTHER END OF THE PARTICULATE WAS TAPERED. THE LENGTH OF THE PARTICLE WAS APPROXIMATELY 50MM LONG. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CUSTOMER REPORT OF HAIR CONTAMINATION ISSUE WAS CONFIRMED. IT IS NOT POSSIBLE TO CONCLUSIVELY RELATE THE COMPLAINT TO A MANUFACTURING NONCONFORMANCE AS THE PRODUCT PACKAGING WAS RECEIVED OPENED; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "HAIR WAS FOUND UNDER THE THREE-WAY STOPCOCK IN THE KIT RIGHT AFTER THE KIT WAS OPENED BEFORE USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450752 PRESEP CENTRAL VENOUS OXIMETRY SET PRESEP CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HSJD 59689193

    Patients

    Seq Age Sex Outcome Treatment
    1