BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SET: 8.5 FR

    MDR report key: 2150552 · Received June 22, 2011

    Report

    Report Number
    1036844-2011-00201
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K940079
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE CATH-GARD SLEEVE WAS FOUND SEPARATED FROM THE HUB AND THE CATH-GARD WAS FOUND RUPTURED. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI SET: 8.5 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. RF0076447

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK