BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 1910603 · Received November 30, 2010

    Report

    Report Number
    1820334-2010-00597
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 22, 2010
    Report Date
    November 1, 2010
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LESS THAN OR EQUAL TO 10 DAYS AGO. (B)(4). PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. THE SEPARATED TIP WAS ALSO RETURNED. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. AN EXAMINATION OF THE RETURNED DEVICE VERIFIES THE SEPARATION OF THE WIRE GUIDE. THE REASONS FOR THIS TYPE OF DEVICE FAILURE ARE TYPICALLY: DIFFICULTY WITHDRAWING THE DEVICE, OR THE WIRE GUIDE IS DAMAGED THROUGH CONTACT WITH THE NEEDLE OR OTHER INSTRUMENT. IT SHOULD BE NOTED THAT NO SIGNS OF DAMAGE COULD BE FOUND. THEREFORE, AT THIS TIME WE CANNOT DETERMINE WITH ANY DEGREE OF CERTAINTY WHY THIS FAILURE OCCURRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AS REPORTED TO THE FDA BY CUSTOMER. "ATTEMPTED TO THREAD NEEDLE, MET SLIGHT RESISTANCE. STOPPED AND ATTEMPTED TO PULL WIRE AND NEEDLE OUT, RESISTANCE NOTED AGAIN. PULLED NEEDLE OUT OF THE WIRE WITH RESISTANCE AT THE TOP OF THE TISSUE AT THE INSERTION SITE UNDER THE SKIN, LIGHTLY (WITH NO FORCE). PULLED WIRE OUT WITH COVERING OF WIRE LEFT IN TISSUE. USING FLUOROSCOPY INSIDE ONE 1 INCH INCISION, PIECE OF WIRE WAS PULLED OUT. AREA CLEANED AND SUTURED, THEN COVERED WITH DERMABOND." PT REPORTED BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC NA 2549447

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention