BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7FR X 2 0CM

    MDR report key: 2102068 · Received April 14, 2011

    Report

    Report Number
    3006425876-2011-00027
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 18, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    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 EVALUATION: AN ARROW RAULERSON SYRINGE (ARS) AND A SWG WERE RETURNED FOR ANALYSIS. THE ENTIRE LENGTH OF THE SWG WAS INSPECTED VISUALLY. THE SWG WAS KINKED APPROXIMATELY 23CM FROM THE DISTAL END. NO OTHER KINKS, STRETCHING OR OTHER DAMAGE OR DEFECTS WERE OBSERVED. A MANUAL TUG TEST ON BOTH ENDS OF THE SWG FOUND THE PROXIMAL WELD INTACT AND THE DISTAL END OF THE SWG ELONGATED UNDER TENSION. THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD, THEREFORE, THE SWG WAS UNRAVELED WITHOUT ELONGATION. MICROSCOPIC EXAMINATION OF THE WELDS FOUND BOTH WELDS WERE TYPICAL, FULL AND SPHERICAL. THE DIAMETER OF THE SWG WAS MEASURED AND WITHIN SPECIFICATION. THE STRAIGHT END OF THE SWG PASSED THROUGH THE ARS WITHOUT DIFFICULTY. WHEN THE KINK ENTERED THE SYRINGE, INCREASED RESISTANCE FROM THE KINK AND STRETCHING OF THE COILS PREVENTED THE SYRINGE FROM PASSING OVER THE INKED PORTION OF THE SWG. INSTRUCTIONS FOR USE DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF SWG DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE SWG. THE DEVICE HISTORY RECORDS FOR THE SWG WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE REPORTED COMPLAINT OF RESISTANCE PASSING THE ARS OVER THE SWG WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE SWG WAS KINKED AND UNRAVELED AT THE DISTAL END. NO MANUFACTURING 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 WIRE. THE SELECTED INSERTION SITE AND PATIENT 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/PATIENT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EMERGENCY SURGERY AND CENTRAL VENOUS CATHETER CANNULATION AND AFTER THE INSERTION OF THE SPRING WIRE GUIDE INTO THE ARROW RAULERSON SYRINGE (ARS), IT WAS NOT POSSIBLE TO REMOVE THE SYRINGE. AS A RESULT, ANOTHER CS-16702-E WITH A DIFFERENT LOT NUMBER WAS SUCCESSFULLY PLACED IN THE PATIENT. THE PATIENT OUTCOME IS "FINE." THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF0078024

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR