BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® ELLIK EVACUATOR

    MDR report key: 12584069 · Received October 6, 2021

    Report

    Report Number
    1018233-2021-06244
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 23, 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
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS NOT USED FOR PATIENT TREATMENT. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED SIX UNOPENED (WITH ORIGINAL PACKAGING), DISPOSABLE ELLIK EVACUATORS. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE SIX ELLIK EVACUATORS WAS PACKAGED ASSEMBLED AND ALL COMPONENTS CONNECTING PROPERLY WITHOUT ISSUES. THIS DEVICE IS WITHIN SPECIFICATION. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH ELLIK BLADDER EVACUATOR. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 21JUN2021, STATED THAT THE SEAL DID NOT CLOSE PROPERLY AND THIS ITEM COULD NOT BE USED. THE DEVICE IS ELLIK BLADDER EVACUATOR. PATIENT WAS NOT INVOLVED DURING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO ¿MISALIGNED BASE". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW WAS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH ELLIK BLADDER EVACUATOR. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 21JUN2021, STATED THAT THE SEAL DID NOT CLOSE PROPERLY AND THIS ITEM COULD NOT BE USED. THE DEVICE IS ELLIK BLADDER EVACUATOR. PATIENT WAS NOT INVOLVED DURING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481772 BARD® ELLIK EVACUATOR ELLIK BLADDER EVACUATOR KQT C.R. BARD, INC. (COVINGTON) -1018233 000451 NGCX1558 00801741080814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other