BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1022873 · Received March 28, 2008

    Report

    Report Number
    1036844-2008-00049
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN, THAT TWO PROVIDERS HAVE HAD PROBLEMS WITH THE SPRING WIRE GUIDE (SWG) BREAKING DURING PLACEMENT OF THE CATHETER; ONE PROVIDER HAS HAD THREE INSTANCES. THIS PROVIDER HAS BEEN PLACING NUMEROUS CENTRAL LINES OVER A DECADE. DURING TWO SEPARATE INSERTIONS, THE SWG COMPLETELY SEPARATED IN THE CATHETER RATHER THAN UNCOILING. IN BOTH CASES, THE CLINICIAN WAS ABLE TO REMOVE THE CATHETER WITH THE BROKEN SWG QUICKLY AND THE WIRE WAS NOT LOST IN THE PT'S BLOODSTREAM. THERE HAVE BEEN NO PROBLEMS ADVANCING THE SWG THROUGH THE NEEDLE. THEY HAVE EXPERIENCED SOME RESISTANCE WITHDRAWING THE SWG THROUGH THE CATHETER. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention