BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ELLIK EVACUATOR

    MDR report key: 12081449 · Received June 28, 2021

    Report

    Report Number
    1018233-2021-03866
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 4, 2021
    Report Date
    February 15, 2022
    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
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. ONE SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS USED FOR PATIENT TREATMENT. THE PRODUCT HAD CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED ELLIK EVACUATOR. VISUAL INSPECTION OF THE SAMPLE NOTED THE YELLOW TUBE ADAPTER WAS DISCONNECTED FROM THE EVACUATOR. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE WHICH STATES, "THE UNION BETWEEN THE RECIPIENT AND THE TUBE ADAPTER, IT MUST BE FREE AND CLEAR OF BUBBLES AND OPENINGS THAT COULD WEAKEN THE SEALED; MANUALLY PULL THE RECIPIENT AND TUBE ADAPTER TO ASSURE THAT THE UNITED PARTS DO NOT SEPARATE EASILY. A POTENTIAL ROOT CAUSE COULD BE COMPONENTS OUT OF SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿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." THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ELLIK BLADDER EVACUATOR HAD BROKEN.

    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 ELLIK BLADDER EVACUATOR HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977694 BARD ELLIK EVACUATOR BLADDER EVACUATOR KQT C.R. BARD, INC. (COVINGTON) -1018233 000451 NGDZ3949 00801741080814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other