MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC43/HR26 48"; SUTURE, SURGICAL, ABSORBABLE,

Catalog Number	833-137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "[user] called me and said that the capio device deployed and when [doctor] pulled back the pulled had sheared off from the suture.It came off in the patient.They did an xray to see if they could see where the bullet went, and they could not see it in the patient.The physician decided to leave it and open another suture to complete the case.He tried another of the same type of suture and then opened a second capio device.No patient complications".

• Brand Name: MDK VI MF 0 TC43/HR26 48"
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 20451882
• Report Number: 3004365956-2024-00079
• Device Sequence Number: 7203694
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: (01)14026704603920(11)230831(17)260818(10)74H2301301(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2026
• Device Catalogue Number: 833-137
• Device Lot Number: 74H2301301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown