BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2904054 · Received January 3, 2013

    Report

    Report Number
    1036844-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SWG HAD STRETCHED AND LOOKED LIKE A "SLINKY" WHEN IT WAS REMOVED FROM THE CATHETER. THIS OCCURRED IN THE MED SURGERY DEPT. THE CATHETER WAS LEFT INSERTED. THERE WAS NO DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3371 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF2083504

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK