BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8"

    MDR report key: 4173784 · Received August 7, 2014

    Report

    Report Number
    1036844-2014-00339
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTENSIVISTS AND RESIDENTS IN THE ICU ARE EXPERIENCING DIFFICULTY WHEN THREADING THE GUIDE WIRE FROM THIS KIT. THE WIRE SEEMS TO KINK AND BEND WHEN BEING THREADED. IT WAS NOTED MULTIPLE ATTEMPTS WERE MADE FOR INSERTIONS AND THEY ALSO USED SINGLE GUIDE WIRES. THE RESIDENT INDICATED THIS OCCURRED DURING SUBCLAVIAN INSERTIONS WHEN DILATING UP. HE STATED THERE WERE NO ADVERSE PATIENT OUTCOMES. THEY DO NOT KNOW IF THIS CAUSED ANY DELAYS IN TREATMENT. THERE WERE NO PATIENT DEATHS OR COMPLICATIONS REPORTED. THE ICU EDUCATOR STATED THEY HAVE HEARD OF NO OTHER ISSUES FROM ANY OTHER PHYSICIANS AND NONE OF THE SISTER HOSPITALS HAVE HAD ANY ISSUES. IT IS NOT KNOWN HOW MANY TIMES THIS HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464941 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8" ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1