BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 7357361 · Received March 21, 2018

    Report

    Report Number
    3006425876-2018-00190
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    January 15, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER, EACH OF THE EXTENSION LINES AND THE ARROW RAULERSON SYRINGE AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT CAUTIONS THE USER THAT "ALCOHOL AND ACETONE CAN WEAKEN THE STRUCTURE OF POLYURETHANE MATERIALS. CHECK INGREDIENTS OF PREP SPRAYS AND SWABS FOR ACETONE AND ALCOHOL CONTENT." IT NOTES "DO NOT USE ACETONE ON CATHETER SURFACE. ACETONE MAY BE APPLIED TO SKIN BUT MUST BE ALLOWED TO DRY COMPLETELY PRIOR TO APPLYING DRESSING" AS WELL AS "DO NOT USE ALCOHOL TO SOAK CATHETER SURFACE OR TO RESTORE CATHETER PATENCY. CARE SHOULD BE TAKEN WHEN INSTILLING DRUGS CONTAINING HIGH CONCENTRATION OF ALCOHOL. ALWAYS ALLOW ALCOHOL TO DRY COMPLETELY PRIOR TO APPLYING DRESSING. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER, EACH OF THE EXTENSION LINES AND THE ARROW RAULERSON SYRINGE AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THE HUB OF THE INTRODUCER NEEDLE COULDN'T BE CONNECTED TO THE ARS (SYRINGE) TIGHTLY AND FELL APART.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRELIMINARY EVALUATION OF THE RETURNED DEVICE SAMPLES INDICATES THE LUER HUB DAMAGED - FOUND DURING USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE HUB OF THE INTRODUCER NEEDLE COULDN'T BE CONNECTED TO THE ARS (SYRINGE) TIGHTLY AND FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200003 ARROW CVC SET: 3-LUMEN 7 FR X 30 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17L0856

    Patients

    Seq Age Sex Outcome Treatment
    1