BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUISTREAM ALPHACURVE DL CATHETER 14.5 FR, 28CM

    MDR report key: 2010566 · Received March 1, 2011

    Report

    Report Number
    3006260740-2011-00055
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 22, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K090101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    LINE WAS PLACED ON (B)(6) 2010. ON (B)(6) 2011, STAFF NOTICED THE CATHETER HAD FALLEN OUT ABOUT 2-3" FROM THE CUFF. NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUISTREAM ALPHACURVE DL CATHETER 14.5 FR, 28CM MSD C.R. BARD, INC. (BASD) REUH0644

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention