BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1963648 · Received December 21, 2010

    Report

    Report Number
    1036844-2010-00374
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 12, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DEPARTMENT STAFF THAT THE LUER LOCK CONNECTORS ON THE CANNON CATHETERS BREAK EASILY. THEY CHANGED THE HUB CONNECTION WITH NEW ONES. THERE IS NO PATIENT DEATH, INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK