BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 20GA X 8CM

    MDR report key: 9450672 · Received December 11, 2019

    Report

    Report Number
    3006425876-2019-01072
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 11, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K093050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). CORRECTED DATA: RESULTS CODE CORRECTED TO (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE ARTERIAL SPRING WIRE GUIDE (SWG) AND LIDSTOCK FOR INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE CONTAINED ONE DISTINCT KINK. MICROSCOPIC EXAMINATION REVEALED A WHITE STRESS MARK ON THE TUBING AT THE SAME LOCATION AS THE KINK ON THE GUIDE WIRE WHEN FULLY INSERTED. THE LIDSTOCK ALSO HAD A CREASE OVER THE LOCATION OF THE KINK WHEN THE SWG WAS PLACED WITHIN THE PACKAGING. THE DAMAGE OBSERVED IS CONSISTENT WITH DEFECTS RELATED TO SHIPPING AND HANDLING OF OTHER SAC SETS. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE KINK IN THE GUIDE WIRE MEASURED 315MM FROM THE PROXIMAL TIP. THE GUIDE WIRE OUTER DIAMETER MEASURED 0.510MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.508MM-0.533MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE LENGTH MEASURED 351MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 345MM-355MM PER THE GUIDE WIRE PRODUCT DRAWING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT PACKAGING AND THE GUIDE WIRE AND NO RELEVANT ISSUES WERE IDENTIFIED. THE LIDSTOCK WAS REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. THE WORDS "DO NOT BEND" ARE CLEARLY VISIBLE ON THE FRONT OF THE LIDSTOCK. AN ENGINEERING CHANGE ORDER WAS IMPLEMENTED IN (B)(6)2017 TO UPDATE THE PRODUCT LABELING TO CLEARLY INFORM THE CUSTOMER TO NOT BEND THE PRODUCT AND IS INTENDED TO REDUCE THE POTENTIAL FOR PRODUCT DAMAGE. THE REPORTED COMPLAINT THAT THE GUIDE WIRE WAS FOUND KINKED PRIOR TO USE WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE RETURNED GUIDE WIRE CONTAINED ONE DISTINCT KINK. THE GUIDE WIRE TUBING ALSO CONTAINED A STRESS MARK RIGHT OVER THE LOCATION WHERE THE KINK IN THE GUIDE WIRE IS LOCATED WHEN FULLY INSERTED INTO THE TUBING. THE LIDSTOCK ALSO HAD A CREASE OVER THE LOCATION OF THE KINK WHEN THE SWG WAS PLACED WITHIN THE PACKAGING. THE WORDS "DO NOT BEND" ARE CLEARLY VISIBLE ON THE FRONT OF THE LIDSTOCK, WHICH IS INTENDED TO HEIGHTEN CUSTOMER AWARENESS AND MITIGATE THE RISK OF KINKING THE COMPONENTS DURING STORAGE AND SHIPPING OF THIS PRODUCT. THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER DESCRIPTION AND THE SAMPLE RECEIVED, STORAGE AND SHIPPING CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT "NO PATIENTS INVOLVED. FOR JCI REASONS THE ARTERIAL CATHETERS CAN'T BE STOCKED ANY LONGER IN THE CARDBOARD BOX. AS THE CATHETERS AREN'T PACKED IN A HARD COVER TRAY (= IT A FLOPPY POCKET), SOME CATHETERS GOT KINKED. PROBABLY THIS IS A STOCKING ISSUE AND NOT A COMPLAINT. HOWEVER , IT MIGHT BE INTERESTING TO CHECK IF THE ABOVE-MENTIONED LOT NUMBER IS MORE SUSCEPTIBLE FOR THE KINKING OF THE CATHETER AS THIS HAPPENED 3 TIMES (CATHETERS OF THE SAME BOX?)."

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT "NO PATIENTS INVOLVED. FOR JCI REASONS THE ARTERIAL CATHETERS CAN'T BE STOCKED ANY LONGER IN THE CARDBOARD BOX. AS THE CATHETERS AREN'T PACKED IN A HARD COVER TRAY (= IT A FLOPPY POCKET), SOME CATHETERS GOT KINKED. PROBABLY THIS IS A STOCKING ISSUE AND NOT A COMPLAINT. HOWEVER , IT MIGHT BE INTERESTING TO CHECK IF THE ABOVE-MENTIONED LOT NUMBER IS MORE SUSCEPTIBLE FOR THE KINKING OF THE CATHETER AS THIS HAPPENED (B)(4) TIMES (CATHETERS OF THE SAME BOX?)."

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES THE ARTERIAL - SWG KINKED IN PACKAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "NO PATIENTS INVOLVED. FOR JCI REASONS THE ARTERIAL CATHETERS CAN'T BE STOCKED ANY LONGER IN THE CARDBOARD BOX. AS THE CATHETERS AREN'T PACKED IN A HARD COVER TRAY (= IT A FLOPPY POCKET), SOME CATHETERS GOT KINKED. PROBABLY THIS IS A STOCKING ISSUE AND NOT A COMPLAINT. HOWEVER , IT MIGHT BE INTERESTING TO CHECK IF THE ABOVE-MENTIONED LOT NUMBER IS MORE SUSCEPTIBLE FOR THE KINKING OF THE CATHETER AS THIS HAPPENED 3 TIMES (CATHETERS OF THE SAME BOX?)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249304 ARROW ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F19A3042

    Patients

    Seq Age Sex Outcome Treatment
    1