MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR 26 2N; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000861
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual, dimensional, functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No issues or discrepancies were found in the device history record of product code 833-124 / batch 74g2101014 that can be related to the failure mode reported.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
On (b)(6) 2022, in the gynecological operating room, use of a capio polypropylene suture as part of an organ descent.When passing through the ligament to suspend the organs, the suture broke.The dart of the device remained in the ligament.Use of another device of the same reference to remedy the incident.Repetitive incident.To this day there is still a foreign body inside the patient.

• Brand Name: DEK BL MF 0 TC-43/HR 26 2N
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• 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: 13587016
• Report Number: 3004365956-2022-00009
• Device Sequence Number: 11864627
• Product Code: GAW
• UDI-Device Identifier: 14026704603890
• UDI-Public: 14026704603890
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K930738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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 Expiration Date: 07/08/2025
• Device Model Number: IPN000861
• Device Catalogue Number: 833-124
• Device Lot Number: 74G2001014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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
• Patient Sex: Unknown