BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 14115665 · Received April 14, 2022

    Report

    Report Number
    3006425876-2022-00362
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 28, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A SINGLE GUIDE WIRE AND 2-L CVC CATHETER FOR EVALUATION. THE GUIDE WIRE WAS RETURNED WITHIN THE ADVANCER TUBE AND SHOWED EVIDENCE OF USE. THE GUIDE WIRE WAS OBSERVED TO HAVE NO DISTINCT KINKS OR BENDS. THE DISTAL J-BEND WAS INTACT. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 602 MM WHICH IS WITHIN THE SPECIFICATION OF 596-604 MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.80 MM WHICH IS WITHIN THE SPECIFICATION OF 0.788-0.826 MM PER GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDE WIRE. THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS NOT CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. NO KINKS OR BENDS WERE OBSERVED ON THE GUIDE WIRE. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE, NO PROBLEM WAS FOUND. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED DURING PUNCTURE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED DURING PUNCTURE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227246 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21K1977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.