BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-L 7 FR X 8 (20 CM)

    MDR report key: 2243896 · Received August 24, 2011

    Report

    Report Number
    2242445-2011-00112
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) IN THE OPERATING ROOM AT THE HOSP. THE PT WAS TRANSPORTED TO ANOTHER HOSP THE DAY PRIOR TO THE EVENT. DURING AM ROUTINE FLUSHING OF THE TRIPLE LUMEN CATHETER, WHICH WAS CAPPED, THE CATHETER BROKE AT THE YELLOW PART IN TWO PIECES. A MD WAS THERE AND THE CATHETER WAS REMOVED WITH NO HARM TO THE PT. A NEW ONE WAS NOT INSERTED. ADDITIONAL INFO RECEIVED STATED THE PT WAS ALERT AND ORIENTED WITH NO BLOOD LOSS. IT IS UNK HOW LONG THE CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-L 7 FR X 8 (20 CM) ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR