MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48" BSC; DEKLENE MAXX POLYPROPELENE NON

Catalog Number	833-234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Customer complaints cannot be confirmed based only on the information provided.To perform a proper evaluation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However, the device history record of the batch number provided in the complaint report has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint failure mode.Dhrs records for the reported lots shows that the product was assembled and inspected according to our specifications.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.
Event or Problem Description
It was reported that "the capio forceps severed the needle while passing through the sacrospinous ligament.Needle remained in place in the patient's pelvis, unable to be removed.".

• Brand Name: DEK BL MF 0 TC-43 2N 48" 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22512431
• Report Number: 3004365956-2025-00042
• Device Sequence Number: 9403353
• Product Code: GAW
• UDI-Device Identifier: 14026704735317
• UDI-Public: (01)14026704735317(11)230404(17)280404(10)74D2300393(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 833-234
• Device Lot Number: 74D2300393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown