MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK MX BL MF 6-0 XT-1 2N 30"X4; SUTURE, NONABSORBABLE, POLYPR

Catalog Number	D-7076M4K
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
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 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.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "needle is popping off of suture during procedure".Additional information received states that "when the surgeon is tying knots or when he goes through the vein graft and pulls up, the needle is popping off easily.At least 2 extra packs were opened to get on that didn't pop off.All were from same lot number.It appears to be from the same event.No other information was provided".No patient harm or injury.The patient status is reported as "fine".See associated mdrs # 3004365956-2024-00086 and 3004365956-2024-00087.

• Brand Name: DEK MX BL MF 6-0 XT-1 2N 30"X4
• Common Device Name: SUTURE, NONABSORBABLE, POLYPR
• 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: 20832210
• Report Number: 3004365956-2024-00088
• Device Sequence Number: 18359125
• Product Code: GAW
• UDI-Device Identifier: 14026704637031
• UDI-Public: (01)14026704637031(11)240119(17)290116(10)74A2400659(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153076
• 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): 11/26/2024

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 Catalogue Number: D-7076M4K
• Device Lot Number: 74A2400659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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