MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR26 2N 36" BSC; DEKLENE MAXX POLYPROPELENE NON

Model Number	DEK BL MF 0 TC-43/H
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during suture placement, the dart detached from the suture and remained in the ligament.It is suspected that the dart did not insert properly into the carrier and was therefore cut off during placement.Completed the procedure with another capio slim, the dart remains in the ligament since it is too small to get it out.Over time the dart will be encapsulated by the body.Surgeon tried to remove the dart but with no success".No patient harm or injury.The patient status is reported as "expected to fully recover".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was reported.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.
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.A device history record review was performed on two potential lot numbers, and no relevant findings were identified.If the sample becomes available this investigation will be updated with the evaluation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during suture placement, the dart detached from the suture and remained in the ligament.It is suspected that the dart did not insert properly into the carrier and was therefore cut off during placement.Completed the procedure with another capio slim, the dart remains in the ligament since it is too small to get it out.Over time the dart will be encapsulated by the body.Surgeon tried to remove the dart but with no success".No patient harm or injury.The patient status is reported as "expected to fully recover".

• Brand Name: DEK BL MF 0 TC-43/HR26 2N 36" BSC
• Common Device Name: DEKLENE MAXX POLYPROPELENE NON
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18212510
• Report Number: 3004365956-2023-00074
• Device Sequence Number: 6464149
• Product Code: GAW
• UDI-Device Identifier: 14026704735324
• UDI-Public: 14026704735324
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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 Model Number: DEK BL MF 0 TC-43/H
• Device Catalogue Number: 833-235
• Device Lot Number: 74J2201865
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown