BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 16 CM

    MDR report key: 2241185 · Received August 17, 2011

    Report

    Report Number
    1036844-2011-00273
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE. DEVICE EVAL: ONE SWG AND ONE 3-LUMEN CATHETER MARKED ARROW-HOWES 12 FR X 16 CM ON THE HUB WERE RETURNED FOR ANALYSIS. THERE WAS DRIED BLOOD VISIBLE IN THE DISTAL EXTENSION LINE OF THE CATHETER. THE SWG WAS UNRAVELLED AT THE DISTAL END AND KINKED AT THE PROXIMAL END. THE CORE WIRE WAS SEPARATED ADJACENT TO THE WELD AT THE DISTAL END. SLIGHT DISCOLORATION WAS OBSERVED AT THE BROKEN END OF THE CORE WIRE, WHICH IS CONSISTENT WITH PROXIMITY TO A WELD. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE WIRE IN THE AREA OF THE BREAK. THE PROXIMAL WELD WAS INTACT. THE CORE WIRE WAS MEASURED AND BASED UPON THE MEASURED LENGTH OF THE BROKEN CORE WIRE; NO PIECES APPEAR TO BE MISSING. THE OUTSIDE DIAMETER OF THE SWG WAS MEASURED AT THE PROXIMAL END OF THE WIRE AND MET SPECIFICATION. A .035" SWG FROM LAB INVENTORY WAS PASSED THROUGH THE DISTAL TIP OF THE CATHETER UNTIL IT MET THE DRIED BLOOD IN THE EXTENSION LINE, INDICATING NO PROBLEM WITH THE CATHETER. THIS PRODUCT'S INSTRUCTION BOOKLET PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF SWG DAMAGE DURING USE. IT STATES THAT IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE SWG AFTER CATHETER PLACEMENT, THE SWG MAY BE KINKED ABOUT THE TIP OF THE CATHETER WITHIN THE VESSEL. IN THIS CASE IT IS RECOMMENDED TO WITHDRAW THE CATHETER RELATIVE TO THE SWG ABOUT 2-3 CM AND THEN ATTEMPT TO REMOVE THE SWG. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE SWG AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE SWG. THE DEVICE HISTORY RECORDS FOR THE SWG WERE REVIEWED WITH NO RELEVANT FINDINGS. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MFG RELATED CAUSE. THE REPORT OF DIFFICULTY WITHDRAWING THE SWG FROM THE CATHETER WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE SWG WAS UNRAVELED AND KINKED. NO MFG DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW SWG'S ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE THAT EXCEEDS THE MINIMUM FORCE SPECIFIED BY THE ISO STANDARD FOR THIS SIZE SWG. THE SELECTED INSERTION SITE AND PT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF SWG KINKING. SWG BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. QUARTERLY TRENDING INDICATES A LOW, STABLE RATE FOR UNRAVELED OR SEPARATED SWG COMPLAINTS. BASED ON THESE CIRCUMSTANCES, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PT RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO DIFFICULTY WHEN ADVANCING THE SPRING WIRE GUIDE (SWG) IN THE RIGHT JUGULAR VEIN. HOWEVER, WHEN WITHDRAWING THE SWG FROM THE CATHETER RESISTANCE WAS MET AND AS A RESULT, BOTH THE SWG AND CATHETER WERE REMOVED TOGETHER. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 12 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK