BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-L CVC KIT: 7 FR X 20 CM

    MDR report key: 6092434 · Received November 10, 2016

    Report

    Report Number
    1036844-2016-00569
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE EMERGENCY DEPARTMENT. THE PHYSICIAN STATED THE GUIDE WIRE HAS UNRAVELED DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. NO PATIENT DEATH OR COMPLICATIONS REPORTED. FOLLOW UP INFORMATION STATES THE GUIDE WIRE WAS BEING FED THROUGH THE NEEDLE. THE GUIDE WIRE BECAME STUCK DURING INSERTION OR REMOVAL IN SOME CASES. A SECOND KIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT CARE WAS DELAYED. IN EACH CASE THE PHYSICIAN HAD TO REMOVE THE NEEDLE TO SAFELY REMOVE THE WIRE AND THEN RE-ESTABLISH ACCESS. ON AT LEAST ONE OCCASION THEY HAD TO USE A DIFFERENT INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743087 3-L CVC KIT: 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F16E0704

    Patients

    Seq Age Sex Outcome Treatment
    1