MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK MX BL MF 8-0 XT-6.5 2N 24"X1; SUTURE, NONABSORBABLE, POLYPR

Model Number	IPN028986
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).No issues or discrepancies were found in the device history record of product code d-7505m1k/batch 74h2202316 that can be related to the failure mode reported.
Event or Problem Description
Reported issue: the needle was popping off the suture.
Event or Problem Description
Reported issue: the needle was popping off the suture.
Additional Manufacturer Narrative
(b)(4).Two sealed pouches of the part number d-7505m1k with batch number 74h2202316 were received.No damage was detected in the physical s amples.Per failure mode reported no other visual inspection was required.No issues or discrepancies were found in the production device history record of this product.Based on the findings during functional inspection, customer complaint cannot be confirmed.Test results were acceptable according to the procedures of the manufacturing process of this product code.No issues or discrepancies were found in the production dhr of this product.

• Brand Name: DEK MX BL MF 8-0 XT-6.5 2N 24"X1
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16488109
• Report Number: 3004365956-2023-00012
• Device Sequence Number: 6758898
• Product Code: GAW
• UDI-Device Identifier: 14026704637277
• UDI-Public: 14026704637277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: IPN028986
• Device Catalogue Number: D-7505M1K
• Device Lot Number: 74H2202316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown