BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 13 CM

    MDR report key: 1934598 · Received November 24, 2010

    Report

    Report Number
    1036844-2010-00355
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    April 23, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    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 2-LUMEN CATHETER AND ONE SWG WERE RETURNED FOR EVAL. THE CATHETER BODY HAD KINKING BETWEEN THE 6 AND 7 CM MARKING AND ALSO AT APPROXIMATELY 4 CM FROM THE DISTAL END. THE SWG WAS UNRAVELED IN THE MIDDLE. THE DISTAL WELD WAS INTACT AND THERE WERE MULTIPLE KINKS/BENDS AT THE DISTAL END. THE CORE WIRE HAD SEPARATED ADJACENT TO THE PROXIMAL WELD. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE WIRE IN THE AREA OF THE BREAK. APPROXIMATELY 15 CM OF THE PROXIMAL COIL WIRE HAD NOT UNRAVELED. BASED UPON THE MEASURED LENGTH OF THE BROKEN CORE WIRE, NO PIECES APPEARED TO BE MISSING. THE OUTSIDE DIAMETER WAS MEASURED AT THE DISTAL END AND NEAR THE MIDDLE OF THE SWG AND MET SPECIFICATION. A .018" LAB WIRE PASSED THROUGH THE CATHETER WITH MINIMAL RESISTANCE. THE PRODUCTS' INSTRUCTIONS BOOKLET DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF SWG DAMAGE DURING USE. 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 AND CATHETER WERE REVIEWED AND THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MFG RELATED CAUSE. THE REPORT THAT THE SWG KINKED DURING REMOVAL WAS CONFIRMED THROUGH EXAM OF THE RETURNED SAMPLE. THE INVESTIGATION ALSO FOUND THAT THE SWG HAD UNRAVELED. SWG'S OF THIS SIZE ARE DESIGNED AND MFG TO WITHSTAND A TENSILE FORCE OF 2.0 LBS FORCE. THE SELECTED INSERTION SITE AND PT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF SWG KINKING. 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 ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPRING WIRE GUIDE (SWG) WAS KINKED AND CONSEQUENTLY CLOSED THE FLOW OF THE CATHETER. AS A RESULT, THE DEVICE WAS EXCHANGED FOR ANOTHER CATHETER. THE OUTCOME OF THE PT IS "UNK." THERE IS NO FURTHER INFO ON THIS EVENT. THERE WERE NO PT COMPLICATIONS OR DELAY IN THERAPY NOTED. NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 4 FR X 13 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF9113283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK