BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1500CC QUICK-FIT SUCTION LINER

    MDR report key: 14316738 · Received May 7, 2022

    Report

    Report Number
    3011198121-2022-00003
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 11, 2022
    Manufacturer
    BEMIS DE MEXICO
    Product Code
    GCX
    UDI-DI
    00073088159533
    PMA / PMN Number
    K771737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE SECOND OCCURRENCE REPORTED TO BEMIS FOR A 1500CC LINER LEAK. THERE WERE TWO LINERS THAT LEAKED SUCTIONED CONTENT INTO THE OUTER CANISTER. THIS REPORT IS CAPTURING THE INFORMATION FROM THE EVENT ON 4/5/2022 LOT 202605. THE OTHER LINER LEAKED ON 3/31/22 AND THAT LOT NUMBER COULD NOT BE CONFIRMED. THE LINER LOT SIZE ARE 20,000 AND ARE SOLD TO MANY CUSTOMERS AND THIS IS THE ONLY COMPLAINT RECEIVED. THE SOURCE OF THE LEAK COULD NOT BE IDENTIITED.

    Description of Event or Problem · 0

    CAREMOUNT MEDICAL P.C. HAD TWO MORE EVENTS OF THE BEMIS LINER 1504RBM N LEAKING SUCTIONED CONTENTS INTO THE OUTER HARD CANISTER. THIS REPORT IS FOR THE EVENT ON 4/5/22 LOT 202605.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889472 BEMIS 1500CC QUICK-FIT SUCTION LINER SUCTION LINER GCX BEMIS DE MEXICO 1504RBM N 202605 00073088159533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown