BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AU-00420-MAJO

    MDR report key: 8208343 · Received January 2, 2019

    Report

    Report Number
    3006425876-2019-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    November 27, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE SINGLE LUMEN MIDLINE CATHETER FOR EVALUATION. THE CATHETER BODY WAS CUT JUST BELOW THE 13CM MARK. THE SEPARATED PORTION WAS NOT RETURNED BY THE CUSTOMER. THE DEVICE SHOWED SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL INSIDE THE EXTENSION LINE. AFTER FAILING FUNCTIONAL TESTING, THE CATHETER EXTENSION LINE WAS MICROSCOPICALLY EXAMINED. A SMALL SEPARATION OF THE LUER HUB AND EXTENSION LINE WAS FOUND. THE APPEARANCE OF THE DAMAGE IS CONSISTENT WITH A CONTINUOUS TENSILE FORCE ON THE LUER HUB AND EXTENSION LINE BODY, WHICH CAUSED THE EXTENSION LINE TO BE PULLED OUT FROM THE HUB. THE CATHETER BODY WAS CUT 78MM FROM THE JUNCTURE HUB. THE OUTER DIAMETER OF THE EXTENSION LINE MEASURED .0865", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .081"-.091" PER EXTENSION LINE PRODUCT DRAWING. THE INNER DIAMETER OF THE EXTENSION LINE MEASURED .0575", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .052"-.062" PER EXTENSION LINE PRODUCT DRAWING. THE CATHETER WAS FUNCTIONALLY TESTED BY CLAMPING OFF THE DISTAL END OF THE CATHETER AND ATTACHING A LAB INVENTORY SYRINGE FILLED WITH WATER. WHEN THE PLUNGER WAS COMPRESSED, WATER LEAKED OUT OF THE EXTENSION LINE NEAR THE LUER HUB. A MANUAL TUG TEST CONFIRMED THE EXTENSION LINE BODY WAS SECURE WITHIN THE LUER HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING ISSUE. THE IFU PROVIDED WITH THE KIT CAUTIONS THE USER, "CHECK INGREDIENTS OF PREP SPRAYS AND SWABS BEFORE USING. SOME DISINFECTANTS USED AT CATHETER INSERTION SITE CONTAIN SOLVENTS WHICH CAN ATTACK THE CATHETER MATERIAL. ALCOHOL AND ACETONE CAN WEAKEN THE STRUCTURE OF POLYURETHANE MATERIALS." THE IFU ALSO WARNS, "OPEN CATHETER CLAMP PRIOR TO INFUSION THROUGH LUMEN TO REDUCE RISK OF DAMAGE TO EXTENSION LINE FROM EXCESSIVE PRESSURE." THE CUSTOMER REPORT OF AN EXTENSION LINE LEAK WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE RETURNED EXTENSION LINE WAS PARTIALLY SEPARATED AT THE LUER HUB WHICH ALLOWED LEAKING TO OCCUR. THE APPEARANCE OF THE DAMAGE IS CONSISTENT WITH A CONTINUOUS TENSILE FORCE BEING PLACED ON THE LUER HUB AND EXTENSION LINE BODY. THE RETURNED SAMPLE PASSED ALL RELEVANT DIMENSIONAL TESTING AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT THAT THE LEAKING WAS ONLY OBSERVED AFTER A PERIOD OF SUCCESSFUL USE AND THE APPEARANCE OF THE DAMAGE ON THE RETURNED SAMPLE, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINT OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE DEVICE WAS INSERTED ON (B)(6) 2018 AND REMOVED ON (B)(6) 2018 WHEN IT BEGAN TO LEAK AT THE POINT WHERE THE CATHETER EXTENSION MEETS THE HUB.THE DEVICE WAS REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (CATALOG#) NOT INTENDED FOR SALE IN THE US. SIMILAR DEVICE/COMPONENT SOLD IN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DEVICE WAS INSERTED ON (B)(6) 2018 AND REMOVED ON (B)(6) 2018 WHEN IT BEGAN TO LEAK AT THE POINT WHERE THE CATHETER EXTENSION MEETS THE HUB.THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966 ARROW AU-00420-MAJO CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F16M0103

    Patients

    Seq Age Sex Outcome Treatment
    1