BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14FX24CM DUO-FLOW 400 XL

    MDR report key: 2161804 · Received July 8, 2011

    Report

    Report Number
    2518902-2011-00072
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 28, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 14F X 24CM DUO-FLOW 400 XL WAS RETURNED FOR EVAL. A VISUAL EXAMINATION OF THE CATHETER REVEALED THAT THE SUTURE WING IS NOT ASSEMBLED ON THE HUB. THE SUTURE WING WAS RETURNED LOOSE IN THE BAG. THE INNER DIAMETER OF THE SUTURE WING WAS WITHIN THE DIMENSIONAL SPECIFICATION. A REVIEW OF THE MFG RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THE SUTURE WING OF THE RETURNED DEVICE WAS REASSEMBLED ON THE HUB AND THE FORCE TO REMOVE IT WAS MEASURED. THE FORCE REQUIRED TO REMOVE THE SUTURE WING WAS 18.23 LB-F. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT; HOWEVER IT APPEARS THAT EXCESSIVE FORCE WAS APPLIED, ENOUGH TO DISLODGE THE CATHETER FROM THE SUTURE WING. THERE IS NO EVIDENCE OF A MFG DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX DAYS AFTER THE CATHETER WAS INSERTED, AND DURING THE CLEANING OF THE BANDAGES, AN UNUSUAL MOBILITY OF THE CATHETER WAS NOTED. THE BLUE SUTURE WING, WHICH WAS ATTACHED TO THE PT SKIN WITH THREADS, SEPARATED FROM THE CATHETER ITSELF. THE CATHETER WAS INSERTED FEMORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14FX24CM DUO-FLOW 400 XL HEMODIALYSIS CATHETER MSD MEDCOMP DFXL149MTB MAXB790

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention