BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BO

    MDR report key: 18565598 · Received January 23, 2024

    Report

    Report Number
    3003898360-2024-00093
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 4, 2024
    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). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED BY THE PHOTO. THE COMPLAINT OF BROKEN PACKAGE - STERILITY COMPROMISED WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE UNIT OF 528235 VISISTAT 35W 6/BOX FOR INVESTIGATION. THE INDIVIDUAL RETURNED UNIT WAS AN UNOPENED SAMPLE IN ITS ORIGINAL PACKAGING. THE PACKAGING OF THE RETURNED UNIT WAS OBSERVED TO BE DAMAGED, WITH CRACKING NEAR THE TIP OF THE DEVICE WHERE THE STAPLES ARE EJECTED AND OPEN EDGES AT THE RIGHT SIDE OF THE PACKAGING. THE STERILE BARRIER OF THE RETURNED SAMPLE IS COMPROMISED DUE TO THE PACKAGING DAMAGE. A DHR REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS THE SAMPLE IS PENDING TO BE 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 . A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT"25 DEC 2023, THE PACKAGE WAS FOUND BROKEN DURING INSPECTION. ALL DEVICES HAVE A STERILITY BREACH FOR SURE. THE OUTER BOX WAS NOT DAMAGED." NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT"25 DEC 2023, THE PACKAGE WAS FOUND BROKEN DURING INSPECTION. ALL DEVICES HAVE A STERILITY BREACH FOR SURE. THE OUTER BOX WAS NOT DAMAGED." NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648962 VISISTAT 35W 6/BO STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73H2300103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NONE REPORTED| NONE REPORTED