BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 19940049 · Received August 8, 2024

    Report

    Report Number
    3006425876-2024-00763
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    00801902105455
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, OPENED CVC SET INCLUDING ONE, 2-LUMEN CATHETER FOR ANALYSIS. SIGNS OF USE WERE OBSERVED. INITIAL VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES ON THE CATHETER. AFTER FAILING FUNCTIONAL TESTING, A HOLE WAS OBSERVED ON THE CATHETER BODY TOWARDS THE JUNCTURE HUB. THE HOLE ON THE CATHETER APPEARS CONSISTENT WITH CONTACT WITH A SHARP INSTRUMENT (I.E. NEEDLE BEVEL). THE HOLE IN THE CATHETER BODY MEASURED 7 MM FROM JUNCTURE HUB. THE CATHETER BODY LENGTH MEASURED 215 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 207-227 MM PER CATHETER PRODUCT DRAWING. THE CATHETER BODY OUTER DIAMETER MEASURED 2.45 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.36-2.46 MM PER CATHETER EXTRUSION PRODUCT DRAWING. THE CATHETER WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS-FOR-USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "FLUSH EACH LUMEN WITH STERILE NORMAL SALINE FOR INJECTION TO ESTABLISH PATENCY AND PRIME LUMEN(S)." A LAB INVENTORY SYRINGE FILLED WITH WATER WAS USED TO FLUSH EACH LUMEN. NO OBVIOUS LEAKAGES OR BLOCKAGES WERE OBSERVED WHEN EACH LUMEN WAS FLUSHED. THE RETURNED CATHETER WAS THEN TESTED PER BS EN ISO 10555-1 SECTION 4.7.1 (AMRQ-000071 REV.15) WHICH STATES THAT THERE SHALL BE NO LIQUID LEAKAGE IN THE FORM OF ONE OR MORE FALLING DROPS WHEN PRESSURIZED TO 300 KPA FOR 30 SECONDS. THE DEVICE WAS CONNECTED TO LAB LEAK TESTER AND PRESSURIZED TO 300 KPA FOR 30 SECONDS WITH THE DISTAL END OCCLUDED. THE EXTENSION LINES WERE CONNECTED INDIVIDUALLY TO THE LEAK TESTER, AND WHEN PRESSURIZED, A LEAK WAS DETECTED. THE LEAK WAS OBSERVED COMING FROM A HOLE ON THE CATHETER BODY TOWARDS THE JUNCTURE HUB. A MANUAL TUG TEST CONFIRMED THAT THE EXTENSION LINES WERE SECURE WITHIN THEIR RESPECTIVE LUER HUBS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS 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 ONLY AT INDICATED STABILIZATION LOCATIONS. 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." THE REPORT OF A LEAKING CATHETER BODY WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. A HOLE WAS OBSERVED ON THE CATHETER BODY TOWARDS THE JUNCTURE HUB. THE APPEARANCE OF THE HOLE ON THE CATHETER IS CONSISTENT WITH CONTACT WITH A SHARP INSTRUMENT (I.E. NEEDLE TIP). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND FUNCTIONAL TESTING OF THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR (CONTACT WITH SHARPS) LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT"(B)(6) 2024, THE DOCTOR FOUND THE CATHETER TO BE LEAKING DURING USED ON THE PATIENT. INVOLVED 1 PC. THEY CHANGED TO A NEW ONE. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT" (B)(6) 2024, THE DOCTOR FOUND THE CATHETER TO BE LEAKING DURING USED ON THE PATIENT. INVOLVED 1 PC. THEY CHANGED TO A NEW ONE. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069466 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F22L0599 00801902105455

    Patients

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