BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3744944 · Received January 27, 2014

    Report

    Report Number
    1419185-2014-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 27, 2014
    Manufacturer
    BEMIS MFG COMPANY
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED TO OHIO MED CORP ON (B)(6) 2013 BY THE USER FACILITY. EVENT INVOLVES A COLLECTION CANISTER SUPPLIED TO OHIO MED CORP BY BEMIS MANUFACTURING CO. OHIO MED INCLUDES THE CANISTER AS AN ACCESSORY TO OUR DEVICE (CARE-E-VAC 3). SUSPECT DEVICE MANUFACTURER WAS NOTIFIED OF EVENT BY OHIO MED CORP ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE NURSE MENTIONED THAT DURING THEIR DAILY CHECK OF THE CRASH CART EQUIPMENT A NURSE HAD TURNED ON THE CEV3 (OHIO MEDICAL CORPORATION MANUFACTURED DEVICE) AND THE CANISTER (BEMIS DESIGNED AND MANUFACTURED DEVICE) LID SHATTERED WITH PLASTIC PIECES BEING SCATTERED. THERE WAS NO INDICATION OF INJURY OR EXPOSURE TO BODY FLUIDS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60010 NA COLLECTION CANISTER KDQ BEMIS MFG COMPANY AI4080000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA