BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX SHIELD PORT SITE CLOSURE SYSTEM

    MDR report key: 12017677 · Received June 17, 2021

    Report

    Report Number
    1036844-2021-00127
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 11, 2021
    Report Date
    June 14, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HCF
    UDI-DI
    14026704645272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED , AND NO NCRS OR MANUFACTURING-ABNORMALITIES WERE NOTED. PER OUR MEL-100232 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

    SIDE OF WING BROKE WHILE IN PATIENT. NO PATIENT INJURY OR CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (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

    SIDE OF WING BROKE WHILE IN PATIENT. NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918904 WECK EFX SHIELD PORT SITE CLOSURE SYSTEM INSTRUMENT, LIGATURE PASSING A HCF TELEFLEX MEDICAL IPN914218 3353060000 14026704645272

    Patients

    Seq Age Sex Outcome Treatment
    1