BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II-(3/16" KIT) PKE/6 WORLD

    MDR report key: 2494249 · Received March 12, 2012

    Report

    Report Number
    2648666-2012-00078
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 15, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K970714
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETUREND TO THE MFR FOR AN INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO PLACE THE PROTECTIVE SHEATH ONTO THE TROCAR NEEDLE OF THE DEVICE, HE CUT HIS FINGER. HE STATED THE PROTECTIVE COVER APPEARED TO BE TOO SHORT AND DID NOT FULLY COVER THE TROCAR THEREBY CAUSING HIM TO CUT HIS FINGER. THE DOCTOR DID NOT REQUIRE STITCHES BUT DID HAVE BLOOD WORK COMPLETED BECAUSE THE PT WAS (B)(6). SINCE THE EVENT, THE RESULT OF BLOODWORK WERE RETURNED AND WERE (B)(6). NO OTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II-(3/16" KIT) PKE/6 WORLD CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other