BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 9FR

    MDR report key: 2970078 · Received February 15, 2013

    Report

    Report Number
    1036844-2013-00057
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K780532
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS ORIGINALLY REVIEWED AND DETERMINED TO BE NON-REPORTABLE. HOWEVER, UPON EXAMINATION OF THE RETURNED DEVICE SAMPLE, THE EVENT WAS DETERMINED TO BE THE RESULT OF A PRODUCT MALFUNCTION AND THEREFORE, REPORTABLE. FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE OPERATING ROOM, AFTER INSERTING THE SHEATH AND DILATOR, THE USER WAS UNABLE TO REMOVE THE SWG. AS A RESULT, THE SWG, DILATOR, AND SHEATH WERE ALL REMOVED AND A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68810 PSI KIT: 9FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. RF2060896

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK