BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH ¿ CRANIOTOMY TRAY

    MDR report key: 8154677 · Received December 12, 2018

    Report

    Report Number
    8154677
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 2, 2018
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM (OR) CIRCULATING NURSE OPENED 3-0 VICRYL SUTURE POP-OFFS THAT WERE IN THE CRANIOTOMY PACK, AND FOUND AN EXTRA NEEDLE IN IT. IT DID NOT HAVE ANY STRANDS ATTACHED. CRANIOTOMY PACK CATALOG SNE13CRMG5 LOT# 994263 EXP. 06/01/2020. MANUFACTURER RESPONSE FOR NEUROLOGICAL TRAY, CARDINAL HEALTH (PER SITE REPORTER). UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996906 CARDINAL HEALTH ¿ CRANIOTOMY TRAY NEUROLOGICAL TRAY OJG CARDINAL HEALTH 200, LLC SNE13CRMG5 994263

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA