BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 4223742 · Received August 5, 2014

    Report

    Report Number
    1036844-2014-00334
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THIS EVENT OCCURRED IN THE CATH LAB. DURING USE OF THE SHEATH, LEAKAGE OF MEDICAL SOLUTION WAS DETRACTED FROM THE STOPCOCK. AS A RESULT, A NEW KIT WAS OPENED AND THE INSERTION PROCEEDED SUCCESSFULLY. THERE WAS NO REPORTED DELAY IN TREATMENT. THERE WERE NO REPORTED PATIENT INJURIES, COMPLICATIONS, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456536 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. 23F14B0506

    Patients

    Seq Age Sex Outcome Treatment
    1