BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1170219 · Received September 11, 2008

    Report

    Report Number
    1036844-2008-00170
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT "THE SEAL DOES NOT KEEP BLOOD FROM LEAKING WHEN YOU TRY TO INSERT A CATHETER THROUGH IT." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. RF8056694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK