BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14648400 · Received June 9, 2022

    Report

    Report Number
    3003898360-2022-00240
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 30, 2022
    Report Date
    May 31, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). QUANTITY OF (B)(4) FOUND DURING INCOMING INSPECTION BY DISTRIBUTOR. THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W 6/BOX LOT# 73L2100578 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED FIVE PHOTOGRAPHS FOR ANALYSIS. THE COMPLAINT OF BROKEN PACKAGE - STERILITY COMPROMISED WAS ABLE TO BE CONFIRMED BY THE PHOTOGRAPHS. THE CUSTOMER RETURNED 116 UNITS OF 528235 VISISTAT 35W 6/BOX FOR INVESTIGATION. THE INDIVIDUAL RETURNED UNITS WERE UNOPENED SAMPLES IN ORIGINAL PACKAGING. THE PACKAGING OF EACH UNIT WAS OBSERVED TO BE DAMAGED AT THE CORNER OF THE TRAY NEXT TO THE COVER BLOCK AND OPPOSITE THE LIDSTOCK. THESE DEFECTS INCLUDED HOLES NEAR THE TIP OF THE DEVICES WHERE THE STAPLES ARE EJECTED, AS WELL AS MARKS NEAR THE TIP WITH NO CLEAR HOLE THAT PASSES THROUGH THE TRAY. THE STERILE BARRIERS OF THE RETURNED SAMPLES ARE COMPROMISED DUE TO THE PACKAGING DAMAGE. A CAPA WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W 6/BOX LOT# 73L2100578 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. A DIMENSIONAL AND FUNCTIONAL INSPECTION WAS NOT REQUIRED AS A PART OF THIS COMPLAINT INVESTIGATION. THE REPORTED COMPLAINT OF BROKEN PACKAGE - STERILITY COMPROMISED WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 ,THE PACKAGE WAS FOUND BROKEN DURING INSPECTION.

    Description of Event or Problem · 0

    30 MAY 2022 ,THE PACKAGE WAS FOUND BROKEN DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145583 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028493 73L2100578 14026704631787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown