MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Catalog Number	EFX002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that the "shield broke on a female patient.The shield wing came apart.[the doctor] assures the patient was ok and there were no complications.He said everything was fine.He just wanted to know what he did to break the product".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The complaint sample was returned.Paragon medical, the manufacturing site reported: "a review of the dhr showed that there were no abnormalities observed during manufacturing.A review of the returned unit showed that the device was observed to be functioning correctly.Since the device was determined to be functionally acceptable, the complaint cannot be verified and is considered invalid." teleflex will continue to monitor and trend on complaints of this nature.Additional information received on 22 aug 2023 states that "the wings broke open.The device was inside the patient and deployed for suture grasping and broke open.[the surgeon] had to use a hemostat to stretch open the defect to get the device out.Once he did, he hand stitched it closed".The patient status is reported as "fine".
Event or Problem Description
It was reported that the "shield broke on a female patient.The shield wing came apart.[the doctor] assures the patient was ok and there were no complications.He said everything was fine.He just wanted to know what he did to break the product".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17596998
• Report Number: 3011137372-2023-00215
• Device Sequence Number: 6422362
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2024
• Device Catalogue Number: EFX002
• Device Lot Number: 3392490000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female