BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ACCESS TRAY

    MDR report key: 13573203 · Received February 21, 2022

    Report

    Report Number
    9680794-2022-00136
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 1, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE ACCESS CATHETER AND TUBING EXTENSION ASSEMBLY FOR ANALYSIS. INITIAL VISUAL INSPECTION OF THE CATHETER REVEALED A SMALL SLIT IN THE CATHETER BODY, DIRECTLY ADJACENT TO THE HUB. THE CATHETER WAS ALSO KINKED DIRECTLY ADJACENT TO THE HUB. THE TOTAL CATHETER LENGTH MEASURED 1 3/4" WHICH EQUALS THE NOMINAL VALUE OF 1 3/4" PER THE CATHETER GRAPHIC. THE CATHETER OUTER DIAMETER MEASURED 0.046" WHICH IS WITHIN THE SPECIFICATIONS OF 0.044" - 0.046" PER THE CATHETER EXTRUSION GRAPHIC. THE CATHETER BODY INNER DIAMETER AT THE DISTAL TIP MEASURED .031" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .031"-.033" PER THE CATHETER EXTRUSION GRAPHIC. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED CATHETER TO RECREATE THE PRODUCT'S INTENDED USE. THE CATHETER WAS FLUSHED USING A 5CC SYRINGE IN ORDER TO FIND ANY LEAKS OR BLOCKAGES. UPON FLUSHING, WATER LEAKED OUT OF THE SLIT IN THE CATHETER. MANUFACTURING WAS CONTACTED REGARDING THIS COMPLAINT INVESTIGATION. THEY STATED THAT ALL CATHETERS ARE 100% INSPECTED PRIOR TO PACKAGING. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF A CATHETER SPLIT/TORN WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE RETURNED CATHETER HAD A SLIT ADJACENT TO THE HUB WHICH LEAKED WHEN FUNCTIONAL TESTING WAS PERFORMED. A DEVICE HISTORY RECORD REVIEW BASED ON A POTENTIAL LOT NUMBER FROM SALES HISTORY WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE RETURNED SAMPLE AND THE AVAILABLE INFORMATION, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE. CORRECTED DATA: SECTION D.1.-BRAND NAME CORRECTED TO ARROW ACCESS TRAY. SECTION D.4.-CATALOG # CORRECTED TO ASK-04001-BID2.

    Description of Event or Problem · 0

    CUSTOMER REPORTED INSTANCE OF CATHETER FAILURE/FRACTURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED INSTANCE OF CATHETER FAILURE/FRACTURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED INSTANCE OF CATHETER FAILURE/FRACTURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224722 ARROW ACCESS TRAY WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown