BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER NEEDLE SET

    MDR report key: 1698776 · Received May 21, 2010

    Report

    Report Number
    1820334-2010-00230
    Event Type
    Injury
    Date Received
    May 21, 2010
    Report Date
    April 23, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS GIVEN AS (B) (6) 2010 OR (B) (6) 2010. CATALOG #: DRTAN-5.0W-18-10.0-FCH-062493. (B) (4). CUSTOMER RETURNED THE PACKAGING MATERIAL FOR TWO DEVICES FROM TWO SEPARATE LOTS, BUT DID NOT RETURN THE PRODUCT FOR THESE. IN ADDITION, FIVE DEVICES WERE RETURNED IN AN UNOPENED AND UNUSED CONDITION. AN EXAMINATION OF THESE FIVE DEVICES DID NOT REVEAL ABNORMALITIES OR UNUSUAL CHARACTERISTICS. WITHOUT THE ACTUAL COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE NEEDLE SEPARATION. IT IS POSSIBLE THAT THE NEEDLE CANNULA SEPARATED DUE TO EXCESSIVE FLEXING OR OTHER DAMAGE DURING THE PROCEDURE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE NEEDLE BROKE OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE THE NEEDLE WITH NO HARM OR ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER NEEDLE SET DQR CANNULA, CATHETER DQR COOK, INC. NA F2471003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention