BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 4156579 · Received October 7, 2014

    Report

    Report Number
    1722447-2014-00011
    Event Type
    Other
    Date Received
    October 7, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    CAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE, THE DOCTOR PERFORMED SINGLE HANDED RECAPPING AND THE 30G NEEDLE WENT THROUGH THE SIE OF THE CAP. WHEN HE WAS PLACING THE CAPPED NEEDLE INTO THE BIOHAZARD BOX DOCTOR'S GLOVED THUMB WAS PUNCTURED BY THE NEEDLE. DOCTOR REPORTS IT WAS A LOW RISK PT AS FAR AS BLOODBORNE PATHOGENS ARE CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626422 UNIVERSAL BLOCK TRAY 44TRAYS CAZ INTEGRA PAIN MANAGEMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other