BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1625796 · Received February 23, 2010

    Report

    Report Number
    3006425876-2010-00010
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 23, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER WAS PASSED THROUGH THE SHEATH, THE ONE WAY VALVE WAS LEAKING BLOOD INTO THE SHEATH. AS A RESULT, ANOTHER NEW CA-09801-SB WAS SUCCESSFULLY PLACED IN THE PT. ADDITIONAL INFO RECEIVED ON 02/22/2010 STATED THE CATHETER USED IS A BAXTER 7 FR. THIS IS THE ONLY DEPT THAT USES THIS KIT. THERE WERE NO REPORTED CONSEQUENCES TO THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTERNATIONAL INC. ZF9100517

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BAXTER 7 FR CATHETER