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	03/31/2021
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 eve.
Event or Problem Description
During second deployment one of the wings broke inside the patient.Occurrence did not change outcome.There was no patient injury or consequence.
Event or Problem Description
During second deployment one of the wings broke inside the patient.Occurrence did not change outcome.There was no patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).Device was not available for return for examination by an mw subject matter expert although a evaluation: photograph was supplied wherein one of the wings is shown to be broken.Customer was not able to provide lot# but tfx sales history shows it may have come from either lot #3351150000 or 350820000.A review of both device history records was performed.No ncrs for either batch ere 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.

• 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: 11700797
• Report Number: 3011137372-2021-00125
• Device Sequence Number: 19617326
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/09/2021

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 Model Number: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: 00000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1