BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2871712 · Received December 3, 2012

    Report

    Report Number
    3006425876-2012-00123
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WITH THE CVC WAS MOVED FROM INTENSIVE CARE UNIT TO NORMAL WARD. IN TAKEOVER, THE NURSE NOTICED IMMEDIATELY THAT A CVC "LEG" WAS SEVERED. THIS INFORMATION WAS PROVIDED VIA THE COMPETENT AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN