BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN SPINAL NEEDLE TRAY

    MDR report key: 1981200 · Received February 3, 2011

    Report

    Report Number
    MW5019282
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BBRAUN
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPENED BBRAUN PENCAN SPINAL NEEDLE TRAY LOT NUMBER 61127575 EXP 2011-09. WAS IN PROCESS OF OPENING TRAY AND NOTICED THE GLASS SYRINGE INSIDE THE TRAY HAD AN ABNORMAL COLOR. AFTER CLOSER EXAMINATION, NOTICED A DEAD BROWN SPIDER INSIDE THE GLASS SYRINGE. TRAY WAS NOT USED ON THE PATIENT. A NEW TRAY WAS OPENED AND USED. WE TOOK 4 PICTURES AND CALLED THE LOCAL REP FOR BBRAUN TO REPORT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN SPINAL NEEDLE TRAY BBRAUN SPINAL TRAY CAZ BBRAUN PENCAN SPINAL TRAY 61127575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R