BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 10032582 · Received May 7, 2020

    Report

    Report Number
    3006425876-2020-00379
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 17, 2020
    Report Date
    April 20, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED MULTIPLE COMPONENTS FROM A CVC KIT. THE GUIDE WIRE ASSEMBLY WILL BE ANALYZED AS PART OF THIS COMPLAINT INVESTIGATION. NO DEFINITE SIGNS-OF-USE WERE OBSERVED ON ANY OF THE RETURNED COMPONENTS. VISUAL ANALYSIS REVEALED THAT THE RETURNED GUIDE WIRE TUBING/ASSEMBLY WAS NOT ORIENTED CORRECTLY. THE DISTAL END OF THE TUBING HAD FALLEN OUT OF THE STRAIGHT TUBE MOLDED COMPONENT. THIS PREVENTED THE TUBING FROM STAYING IN ITS CIRCULAR ORIENTATION (PER THE SWG ASSEMBLY GRAPHIC). IT IS BEING ASSUMED THAT THIS OCCURRED WHILE IN TRANSIT TO THE MORRISVILLE FACILITY. ANALYSIS OF THE ACTUAL GUIDE WIRE DID NOT REVEAL OTHER DEFECTS OR ANOMALIES OF ANY KIND. THE GUIDE WIRE TOTAL LENGTH MEASURED 603MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 596MM-604MM PER THE GUIDE WIRE GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .79MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF .788MM-.826MM PER THE GUIDE WIRE GRAPHIC. THE GUIDE WIRE WAS PASSED THROUGH THE RETURNED CVC CATHETER. LITTLE TO NO RESISTANCE WAS OBSERVED AS THE GUIDE WIRE WAS ABLE TO PASS COMPLETELY THROUGH THE CATHETER. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELD WERE SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED CAUSE. THE REPORT OF A KINKED GUIDE WIRE WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION. NO KINKS OR ABNORMALITIES WERE OBSERVED ON THE ACTUAL GUIDE WIRE. THE GUIDE WIRE TUBING WAS RETURNED UNCOILED; HOWEVER, IT WAS DETERMINED THAT THIS LIKELY OCCURRED WHILE IN TRANSIT TO THE MORRISVILLE FACILITY. THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THE GUIDE WIRE WAS BENT PRIOR TO USE. A NEW DEVICE WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES SWG KINKED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE GUIDE WIRE WAS BENT PRIOR TO USE. A NEW DEVICE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497733 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F18L0166

    Patients

    Seq Age Sex Outcome Treatment
    1