BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 8FR X 20CM

    MDR report key: 14319096 · Received May 7, 2022

    Report

    Report Number
    3006425876-2022-00402
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 15, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 2-LUMEN CATHETER FOR ANALYSIS. VISUAL INSPECTION REVEALED A KINK IN THE CATHETER BODY NEAR THE JUNCTURE HUB. GIVEN THIS KINK WAS OBSERVED IN THE CATHETER DURING USE, IT IS LIKELY THAT CATHETER PLACEMENT AND POSITIONING CAUSED THE KINK. THE KINK IN THE CATHETER BODY WAS LOCATED 3MM FROM THE JUNCTURE HUB. THE CATHETER BODY TOTAL LENGTH MEASURED 213MM WHICH IS WITHIN THE SPECIFICATION OF 207-227MM PER CATHETER PRODUCT DRAWING. SIMULATED USE OF THE CATHETER WAS PERFORMED PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE KIT WHICH STATES "FLUSH EACH LUMEN WITH STERILE NORMAL SALINE FOR INJECTION TO ESTABLISH PATENCY AND PRIME LUMEN(S)." BOTH EXTENSION LINES WERE FLUSHED USING A 5CC SYRINGE. NO BLOCKAGES OR LEAKS WERE OBSERVED IN EITHER OF THE EXTENSION LINES. A MANUAL TUG TEST CONFIRMED BOTH EXTENSION LINES WERE SECURE TO THEIR RESPECTIVE HUBS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER , "ENSURE CATHETER PATENCY PRIOR TO USE. DO NOT USE SYRINGES SMALLER THAN 10 ML (A FLUID FILLED 1 ML SYRINGE CAN EXCEED 300 PSI) TO REDUCE RISK OF INTRALUMINAL LEAKAGE OR CATHETER RUPTURE. MINIMIZE CATHETER MANIPULATION THROUGHOUT PROCEDURE TO MAINTAIN PROPER CATHETER TIP POSITION." THE CUSTOMER REPORT OF A KINKED CATHETER WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED A KINK NEAR THE JUNCTURE HUB. THE CATHETER MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE AVAILABLE INFORMATION AND THE CUSTOMER REPORT, IT IS LIKELY THAT THIS KINK WAS CAUSED DUE TO CATHETER PLACEMENT OR POSITIONING DURING USE. THEREFORE, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE. CORRECTED DATA: SECTION H.6.-MEDICAL DEVICE PROBLEM CODE CORRECTED TO 2889.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "INCIDENT HAPPENED (B)(6) 2022, 48 HOURS AFTER INSERTION OF THE DEVICE IN SUBCLAVIAN WITH SUCCESS. THE CENTRAL LINE WAS FOUND KINKED AND CUT AT THE LEVEL OF THE JUNCTION HUB." NO PATIENT HARM REPORTED. THE CATHETER WAS REMOVED AND REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "INCIDENT HAPPENED (B)(6) 2022, 48 HOURS AFTER INSERTION OF THE DEVICE IN SUBCLAVIAN WITH SUCCESS. THE CENTRAL LINE WAS FOUND KINKED AND CUT AT THE LEVEL OF THE JUNCTION HUB." NO PATIENT HARM REPORTED. THE CATHETER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296222 ARROW CVC SET: 2-LUMEN 8FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN914889 71F20B1407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED.| NOT REPORTED.