BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"

    MDR report key: 6950904 · Received October 16, 2017

    Report

    Report Number
    1036844-2017-00377
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 2, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE AND LID STOCK FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE GUIDE WIRE CONTAINED FOUR CURVES. THE COILS APPEARED SLIGHTLY CLOSER; HOWEVER, THEY WERE NOT OFFSET OR UNRAVELED. THE RETURNED GUIDE WIRE HAD SLIGHT BENDS 221, 260, 310, AND 363 MM FROM THE PROXIMAL END. THE LENGTH AND OUTER DIAMETER OF THE RETURNED WIRE WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. THE RETURNED GUIDE WIRE WAS ABLE TO PASS THROUGH A LAB INVENTORY CATHETER WITH MODERATE RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE PROXIMAL AND DISTAL WELDS ARE FULLY INTACT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT CUT SPRING-WIRE GUIDE TO ALTER LENGTH. DO NOT WITHDRAW SPRING-WIRE GUIDE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OR DAMAGING OF SPRING-WIRE GUIDE." (CON'T) OTHER REMARKS: THE REPORTED COMPLAINT OF THE GUIDE WIRE KINKING DURING USE WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE RETURNED GUIDE WIRE CONTAINED FOUR SLIGHT BENDS. THE COILS APPEARED SLIGHTLY CLOSER; HOWEVER, THEY WERE NOT OFFSET OR UNRAVELED. A DHR REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. BASED ON THE SAMPLE AS RECEIVED AND THE REPORT THAT THE INCIDENT HAPPENED DURING USE, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE WIRE KINKED DURING INSERTION. A DELAY IN THE PROCEDURE WAS REPORTED. NO PATIENT INJURY OR HARM.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE WIRE KINKED DURING INSERTION. A DELAY IN THE PROCEDURE WAS REPORTED. NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731826 ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 23F17G0262

    Patients

    Seq Age Sex Outcome Treatment
    1