BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® ELLIK EVACUATOR

    MDR report key: 7068106 · Received November 29, 2017

    Report

    Report Number
    1018233-2017-06173
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 2, 2017
    Report Date
    March 2, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KQT
    UDI-DI
    00801741080814
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE (IT WAS REPORTED THAT THE DEVICE LEAKED AT THE BULB DURING USE.) FOR THIS COMPLAINT WAS UNCONFIRMED, THE PROBLEM COULD NOT REPRODUCED. DURING VISUAL EVALUATION THE SAMPLE RETURNED WAS VISUALLY INSPECTED AND NO DISCREPANCIES WERE FOUND. THE SAMPLE WAS ASSEMBLED AND TESTED ACCORDINGLY AND THE RESULTS SHOWED THAT THERE WERE NO LEAKS ON THE SAMPLE RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "FILL WITH SOLUTION. DISPLACE ALL AIR BEFORE USING. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT." (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE LEAKED AT THE BULB DURING USE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "FILL WITH SOLUTION. DISPLACE ALL AIR BEFORE USING. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT." (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED AT THE BULB DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED AT THE BULB DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845437 BARD® ELLIK EVACUATOR BARD ELLIK EVACUATOR DISPOSABLE KQT C.R. BARD, INC. (COVINGTON) -1018233 000451 UNK 00801741080814

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR