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	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Broke when inserting into the fascia.No patient injury.Additional information: the shield part snapped when he inserted into the fascia.Probably too hard and got caught.Nothing fell into the patient.
Additional Manufacturer Narrative
(b)(4), a review of the device history record was performed and no nonconformances or manufacturing abnormalities were noted.A review of the returned device showed that it was bent.All units go through a functional test and a bent unit such as this one would not be able to be sealed within the packaging.Based on the record review, the 100% testing of all units in the lot, and the examination of the returned unit it is determined that this complaint is not valid and it is likely due to operator error.
Event or Problem Description
Broke when inserting into the fascia.No patient injury.Additional information: the shield part snapped when he inserted into the fascia.Probably too hard and got caught.Nothing fell into the patient.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12736588
• Report Number: 3011137372-2021-00314
• Device Sequence Number: 17168557
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/29/2021

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: 12/01/2023
• Device Model Number: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: 3354000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/21/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown