BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1635932 · Received March 12, 2010

    Report

    Report Number
    1036844-2010-00065
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 12, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE PLACING A TRANS VENOUS PACING WIRE THROUGH THE SHEATH, THE ONE WAY VALVE BEGAN TO LEAK BLOOD. THE USER REMOVED THE SHEATH AND MADE A SECOND ATTEMPT WITH ANOTHER NR-09801-S OF A DIFFERENT LOT NUMBER. THE SECOND ATTEMPT WAS MADE AND ALSO ALLOWED BLOOD TO LEAK BACK THROUGH THE VALVE. AS A RESULT, A THIRD SHEATH WAS SUCCESSFULLY USED. THERE WERE NO REPORTED PT CONSEQUENCES. REFERENCE MDR # 1036844-2010-00066 FOR THE 2ND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. RF8032590

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK