BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH KIT: 20GA X 5" (12 CM)

    MDR report key: 6621824 · Received June 8, 2017

    Report

    Report Number
    3003737899-2017-00050
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER RETURNED ONE USED K-04500-001B ARTERIAL CATHETER. IT WAS NOTICED THAT THE BODY OF THE CATHETER WAS CURVED. UPON INSPECTION OF THE TIP IT WAS VIEWED THAT THERE WAS SOME DEFORMATION AND TEARING. WHEN THE TIP WAS INSPECTED FROM AN OVERHEAD POSITION IT COULD BE SEEN THAT THIS DEFORMATION WAS A RESULT OF THE CATHETER TIP HAVING SOMETHING DRAWN AGAINST IT, LIKELY THE SPRING WIRE GUIDE. THE INNER DIAMETER OF THE CATHETER TIP WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO RELEVANT FINDINGS. THE CUSTOMER COMPLAINT OF THE CATHETER TIP BEING SPLIT WAS CONFIRMED UPON INVESTIGATION. THE DEFORMATION IS CHARACTERISTIC OF THAT CAUSED BY A SPRING WIRE GUIDE BEING DRAWN AGAINST A CATHETER TIP. BASED UPON THE TIME OF DISCOVERY AND THE OBSERVED DAMAGE, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE PENDING AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CATHETER HAD DAMPENED WAVE FORM WITHIN THE FIRST HOUR AFTER INSERTION. WHEN THE CATHETER WAS REMOVED IT WAS NOTED THAT IT WAS SHREDDED/KINKED AT THE TIP OF THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CATHETER HAD DAMPENED WAVE FORM WITHIN THE FIRST HOUR AFTER INSERTION. WHEN THE CATHETER WAS REMOVED IT WAS NOTED THAT IT WAS SHREDDED/KINKED AT THE TIP OF THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407596 ARROW ARTERIAL CATH KIT: 20GA X 5" (12 CM) WIRE GUIDE, CATHETER DQX ARROW INTERNATIONAL INC. 13F17B0108

    Patients

    Seq Age Sex Outcome Treatment
    1