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

Model Number	IPN914218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
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
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.
Event or Problem Description
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.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12091467
• Report Number: 3011137372-2021-00166
• Device Sequence Number: 17125053
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 08/11/2023
• Device Model Number: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: 3349880000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.