BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"

    MDR report key: 3960039 · Received May 29, 2014

    Report

    Report Number
    1036844-2014-00225
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURES ARE BEING PERFORMED IN THE EMERGENCY DEPARTMENT. THE CLINICIANS ARE EXPERIENCING DIFFICULTY WHEN THREADING THE DILATOR OVER THE SPRING WIRE GUIDE. THE WIRE IS BECOMING KINKED AND CAUSING ISSUES WHEN THREADING THE CATHETER OVER THE WIRE. THE WIRE IS DIFFICULT TO REMOVE. AS A RESULT, EVERY THING IS BEING REMOVED AND THEY ARE USING A DIFFERENT PRODUCT. THEY DO NOT KNOW IF THIS HAS CAUSED DELAYS IN TREATMENT AND THERE HAS BEEN NO PATIENT HARM. THERE ARE NO PATIENT DEATHS OR COMPLICATIONS REPORTED. THEY DO NOT KNOW HOW MANY TIMES THIS HAS OCCURRED. THE SALES REP STATED SHE PERFORMED AN IN-SERVICE TO THE EMERGENCY DEPARTMENT WHICH WAS HAVING THIS ISSUE AS THIS PRODUCT IS USED ALL OVER THE HOSPITAL. SHE REVIEWED THE ANGLE THEY WERE INSERTING THE DILATOR AND THEY ARE COMING IN AT A HIGH ANGLE. THE CHAIR OF ED FEELS THAT THE GUIDE WIRES FEEL DIFFERENT THAT THEY USUALLY DID. SHE NOTED SINCE HER IN-SERVICE THEY HAVE NOT HAD AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315881 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" ARROWGARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1