BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET

    MDR report key: 14711672 · Received June 16, 2022

    Report

    Report Number
    14711672
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 14, 2022
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE WERE MADE AWARE OF A STERILITY ISSUE BY THE STRYKER REPRESENTATIVE ABOUT CONTAMINATION IN THE PACKAGING OF THE PNEUMOCLEAR SMOKE EVALUATION HIGH FLOW TUBE SET (STRYKER--INSUFFLATION TUBING). CURRENT COMPROMISED LOT NUMBERS INCLUDE: 4025383 (THIS IS THE MOST COMMON LOT NUMBER BY FAR), 4024006, K21N334, K22A009, 4023461, 4023621, K21H210, K21K234, 4020970.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796417 PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH 0620050250 4025383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown