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

Model Number	IPN056767
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2024, in the gynecology unit, during a sacro-spino fixation, there were significant friction forces in the device which made it impossible to fix the suture in the female patient's tissue.The issue persisted despite the use of several wires until the needle mismatched and got stuck in the tissue.The delivery device was replaced, and a new wire was used to perform the procedure.The patient consequences consisted of the persistence of foreign material in the body: the needle was left in the tissues, and there was also an extension of the operating time".Per the customer, there is no additional information regarding the status of the patient.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "on (b)(6) 2024, in the gynecology unit, during a sacro-spino fixation, there were significant friction forces in the device which made it impossible to fix the suture in the female patient's tissue.The issue persisted despite the use of several wires until the needle mismatched and got stuck in the tissue.The delivery device was replaced, and a new wire was used to perform the procedure.The patient consequences consisted of the persistence of foreign material in the body: the needle was left in the tissues, and there was also an extension of the operating time".Per the customer, there is no additional information regarding the status of the patient.
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.A device history record review was performed, and no relevant findings were identified.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• 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: 18669763
• Report Number: 3004365956-2024-00006
• Device Sequence Number: 18195842
• Product Code: GAW
• UDI-Device Identifier: 14026704735324
• UDI-Public: 14026704735324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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 Model Number: IPN056767
• Device Catalogue Number: 833-235
• Device Lot Number: 74C2301874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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: Female