BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX SHIELD PORT SITE CLOSURE SYSTEM

    MDR report key: 12091467 · Received June 30, 2021

    Report

    Report Number
    3011137372-2021-00166
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HCF
    UDI-DI
    14026704645272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO NONCONFORMANCES OR MANUFACTURING ABNORMALITIES WERE NOTED. PER OUR MEL- 00232 ALL UNITS UNDERGO MECHANICAL TENSILE TESTING OF WELD JOINTS ON FLEXED WINGS FOLLOWED BY VISUAL INSPECTION, THEN WINGS ARE AGAIN ACTIVATED FOR SUTURE ALIGNMENT TEST FOLLOWED BY MANUAL PRESSURE TO EACH RETRACTED WING AND VISUAL INSPECTION FOR BREAKS/CRACKS. BASED ON THE RECORD REVIEW AND THE 100% TESTING OF ALL UNITS IN THE LOT; IT IS DETERMINED THAT THIS COMPLAINT IS NOT VALID AGAINST MW LIFE SCIENCES.

    Description of Event or Problem · 0

    A PORTION OF ONE SIDE OF THE WING OF THE EFX SHIELD BROKE OFF WHILE PULLING THE PRODUCT OUT OF THE DEFECT. THE PATIENT WAS NOT INJURED TO MY KNOWLEDGE, NOR HARMED IN ANY WAY. NOT SURE WHY THIS HAPPENED.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    A PORTION OF ONE SIDE OF THE WING OF THE EFX SHIELD BROKE OFF WHILE PULLING THE PRODUCT OUT OF THE DEFECT. THE PATIENT WAS NOT INJURED TO MY KNOWLEDGE, NOR HARMED IN ANY WAY. NOT SURE WHY THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991938 WECK EFX SHIELD PORT SITE CLOSURE SYSTEM INSTRUMENT, LIGATURE PASSING A HCF TELEFLEX MEDICAL IPN914218 3349880000 14026704645272

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.