BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 1994267 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00023
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE KIT WAS OPENED, THEY FOUND THE SIMPLICITY HEMODIALYSIS MICRO-PUNCTURE SET WAS INCLUDED INSTEAD OF A REGULAR MICRO-PUNCTURE SET. THE CUSTOMER CHOSE TO USE THE KIT ANYWAY AND UTILIZED THE SIMPLICITY MICRO-PUNCTURE SET SUCCESSFULLY FOR THE PT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS. FOZ ARROW INTERNATIONAL INC RF0127976

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK