BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 1925124 · Received November 18, 2010

    Report

    Report Number
    1925124
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PORTEX LUMBAR PUNCTURE, INFANT PRE-PACKAGED TRAY WAS OPENED TO USE ON AN INFANT AND IT WAS NOTICED THAT THE 1% LIDOCAINE HCI 10MG/ML GLASS VIAL BY HOSPIRA, INC WAS BROKEN. THE WHOLE GLASS TOP HAD BEEN SNAPPED OFF AND THE VIAL WAS EMPTY, HOWEVER THE TRAY LINER WAS DRY WITHOUT ANY SIGNS OF SLIVERS OF GLASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX LUMBAR PUNCTURE TRAY BSO SMITHS MEDICAL ASD, INC LUMBAR PUNCTURE, INFANT 22G QUINCKE 881403A

    Patients

    Seq Age Sex Outcome Treatment
    1 *