BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BO

    MDR report key: 18524905 · Received January 17, 2024

    Report

    Report Number
    3003898360-2024-00057
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    August 2, 2023
    Report Date
    December 26, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: 200 STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM PART NUMBER 528235 VISISTAT 35W 6/BOX LOT# 73M2300456 THE STAPLERS WERE VISUALLY INSPECTED, AND ISSUE REPORTED "BROKEN PACKAGE - STERILITY COMPROMISED" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE REPORT STATES "2 AUG 2023 ,THE PACKAGE WAS FOUND BROKEN DURING INSPECTION." NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    THE REPORT STATES (B)(6). 2023 ,THE PACKAGE WAS FOUND BROKEN DURING INSPECTION." NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101001 VISISTAT 35W 6/BO STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73L2100054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown