BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8391167 · Received March 5, 2019

    Report

    Report Number
    3006425876-2019-00175
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 21, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 3-LUMEN CVC FOR EVALUATION. THE PROXIMAL EXTENSION LINE CONTAINED ALL THREE SIDE CLAMPS AND A SUTURE WAS TIED AROUND THE LUMEN. VISUAL EXAMINATION REVEALED THE PROXIMAL EXTENSION LINE WAS SEPARATED ABOUT HALFWAY DOWN THE LUMEN, THE SEPARATED PORTION WAS NOT RETURNED. THE POINT OF SEPARATION APPEARED SMOOTH, INDICATING THE LUMEN CAME IN CONTACT WITH A SHARP OBJECT (SCISSORS, NEEDLE, ETC). THE DISTAL AND MEDIAL LUMENS CONTAINED ADHESIVE MATERIAL ON THE BODIES. THE RETURNED PROXIMAL LUMEN WAS CUT TO 54 MM. THE DISTAL AND MEDIAL EXTENSION LINES WERE FUNCTIONALLY TESTED FOR LEAKS BY FLUSHING WATER USING A LAB INVENTORY SYRINGE. NO LEAKS OR BLOCKAGES WERE DETECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT FOUND IN SALES HISTORY WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT SECURE, STAPLE AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE O NLY AT INDICATED STABILIZATION LOCATIONS." THE CUSTOMER REPORT OF A SEPARATED EXTENSION LINE WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE PROXIMAL EXTENSION LINE WAS CUT ABOUT HALFWAY DOWN THE LUMEN. THE POINT OF SEPARATION APPEARED SMOOTH, INDICATING THAT CONTACT WITH SHARPS CAUSED THE DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE STAFF FOUND THE CATHETER CUT. THE DEVICE WAS REMOVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE STAFF FOUND THE CATHETER CUT. THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184656 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1