MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36"; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000859
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
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
Capio suture broke off inside patient.Possible capio hand piece or suture error.The dart from the capio suture broke off.The doctor said it malfunctioned and the suture dart came off or fell off or was cut off and he could not capture the suture and the dart is now left inside the patient.Cannot retrieve.
Event or Problem Description
Capio suture broke off inside patient.Possible capio hand piece or suture error.The dart from the capio suture broke off.The doctor said it malfunctioned and the suture dart came off or fell off or was cut off and he could not capture the suture and the dart is now left inside the patient.Cannot retrieve.
Additional Manufacturer Narrative
(b)(4).No issues or discrepancies were found in the device history record of product code 833-123 / batch 74h1901360 that can be related to the failure mode reported.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.

• Brand Name: TEV GN BR 0 TC-43/HR26 2N 36"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13427623
• Report Number: 3004365956-2022-00007
• Device Sequence Number: 14778396
• Product Code: GAT
• UDI-Device Identifier: 14026704603876
• UDI-Public: 14026704603876
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021019
• 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): 02/02/2022

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: 08/07/2024
• Device Model Number: IPN000859
• Device Catalogue Number: 833-114
• Device Lot Number: 74H1901360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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: N/A.
• Patient Sex: Unknown