BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 16 CM

    MDR report key: 1910641 · Received November 19, 2010

    Report

    Report Number
    1036844-2010-00350
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A HEART TRANSPLANT AND WAS IN THE SURGICAL INTENSIVE CARE UNIT. DURING PLACEMENT OF LINES AND PREPARATION FOR HEART TRANSPLANT, THE PT EXPERIENCED HIVES AND LOW BLOOD PRESSURE. ADDITIONAL INFORMATION RECEIVED FROM THE CHIEF CERTIFIED REGISTERED NURSE ANESTHESIOLOGIST (CRNA) ON 11/16/2010 INDICATED, THIS PT WAS FEMALE AND HAD MULTIPLE ALLERGIES. IT IS UNCERTAIN THAT THE CATHETER CONTRIBUTED TO THE HIVES OR LOW BLOOD PRESSURE; HOWEVER, THEY COULD NOT RULE IT OUT. THE PT IS ALIVE AND PROGRESSING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other