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

Catalog Number	833-235
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during vaginal cystocele repair, the capio system was used to pass a wire through the sacrospinous ligament.On the right, two wires were inserted normally.On the left, during the passage of the first wire, the stitch at the end of the wire dislodged and got stuck in the ligament (the wire returned without the stitch).The stitch could not be retrieved or located and was left in place.No technical difficulties were encountered during the procedure, and the wire and the capio were handled with care.Clinical consequences and current state of the patient or person involved: no apparent consequences for the patient.".
Additional Manufacturer Narrative
Qn#(b)(4).Customer complaint 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.The device history record of batch number 74f2302371 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr records shows that the tension qa inspection tests met the specifications.Dhr verification shows that the product was assembled & inspected according to our specifications.Additionally, after sterilization process, attachment strength test were performed to the product and the results were acceptable.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available.If the sample becomes available this investigation will be updated with the evaluation results.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21975067
• Report Number: 3004365956-2025-00025
• Device Sequence Number: 9188199
• Product Code: GAW
• UDI-Device Identifier: 14026704735324
• UDI-Public: (01)14026704735324(11)230628(17)280629(10)74F2302371(21)
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2025

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: 833-235
• Device Lot Number: 74F2302371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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: NOT REPORTED
• Patient Sex: Unknown