BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VLOC 90 ABS CLOS DEVICE

    MDR report key: 3170098 · Received June 5, 2013

    Report

    Report Number
    1219930-2013-00425
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GAM
    PMA / PMN Number
    K100257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: KNEE REPLACEMENT. ACCORDING TO THE REPORTER. THE SURGEON BELIEVES THE END OF NEEDLE (THE VERY TIP) HAS BROKEN OFF. HE ADMITS THAT HE IS GRABBING THE NEEDLE BY THE TIP WITH NEEDLE HOLDER AND THAT IS WHAT IS CAUSING DAMAGE. MANAGEMENT AND NURSING STAFF CONCERNED THAT NEEDLE IS BREAKING OFF AND MAY BE LEFT IN PATIENT. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO X-RAY WAS USED TO CHECK FOR NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249391 VLOC 90 ABS CLOS DEVICE V-LOC SUTURE GAM COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES A2M0933X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other