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	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, in the gynecological unit, a capio polypropylene thread was used with capio slim for treatment of prolapse.During the second passage through the ligament to suspend the organs, the thread broke.The dart of the device has remained in the ligament.Use of another device with the same reference to palliate the incident.No consequence for the patient.Isolated incident.To this day the foreign body is still in the patient.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
On (b)(6) 2021, in the gynecological unit, a capio polypropylene thread was used with capio slim for treatment of prolapse.During the second passage through the ligament to suspend the organs, the thread broke.The dart of the device has remained in the ligament.Use of another device with the same reference to palliate the incident.No consequence for the patient.Isolated incident.To this day the foreign body is still in the patient.
Additional Manufacturer Narrative
(b)(4).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.Refer to attachment.Inspection records for suture 158549 lot number 07f2000150 were requested from coventry (us07), no issues or discrepancies were found.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.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 is not being manufactured at the time.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13176877
• Report Number: 3004365956-2022-00004
• Device Sequence Number: 11917205
• Product Code: GAW
• UDI-Device Identifier: 14026704603890
• UDI-Public: 14026704603890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/04/2022
• 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