BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2051375 · Received April 7, 2011

    Report

    Report Number
    1036844-2011-00116
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 EMERGENCY DEPT WAS INSERTING A CENTRAL VENOUS CATHETER INTO THE PT'S SUBCLAVIAN WHEN THE NEEDLE BROKE OFF. AS A RESULT, THE NEEDLE HAD TO BE SURGICALLY REMOVED. ADD'L INFO REC'D ON (B)(6) 2011 FROM THE RISK MGR STATED THE NEEDLE CANNULA PULLED OUT OF THE HUB AND WAS RETAINED IN THE PT. THE PIECE WAS SURGICALLY REMOVED FROM THE PT. THE RISK MGR DID NOT HAVE ANY UPDATES ON THE PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention