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

Model Number	IPN923663
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
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
Reported issue: during a gastric sleeve the device tab snapped off.It was retrieved from patient and a new device was used.No injury reported.
Additional Manufacturer Narrative
(b)(4).The complaint sample was not returned.Paragon medical, the manufacturing site reported: "there were no images of the failing unit, and the unit was misplaced and unavailable for a physical review.A review of the dhr showed that there were molding issues observed with this lot (ref ncr-3659).This issue was sorted per the ncr and the product was repackaged as needed via rw-0879.This product receives 100% functional inspection per the manufacturing instructions, mei-100232, and would have been identified during assembly prior to packaging.While the non-conformance experienced by the end user appears to be similar in nature to the issue observed during manufacturing the non-conformance could not be verified or validated." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported issue: during a gastric sleeve the device tab snapped off.It was retrieved from patient and a new device was used.No injury reported.

• 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 ; 9194332672
• MDR Report Key: 16491631
• Report Number: 3011137372-2023-00028
• Device Sequence Number: 6994286
• Product Code: HCF
• UDI-Device Identifier: 14026704739001
• UDI-Public: 14026704739001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 05/13/2025
• Device Model Number: IPN923663
• Device Catalogue Number: EFX002
• Device Lot Number: 3381420000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 03/06/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown