MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36"; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000859
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
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.A device history review could not be conducted since the lot number was not provided.The customer complaint cannot be confirmed due to the lack of the batch number to perform a proper investigation and determine a root cause.Teleflex will continue to monitor and trend related events.
Event or Problem Description
I would like to report a non-conformity related to the capio suture thread (b)(4).Update: the surgeons described in their report, as follows: since the discontinuation of the supply of absorbable suture thread, where we used sacrospinous fixation for colpus we have had postoperative complications due to the fact that the thread is non-absorbable we have had important granulomas at the site, infectious processes at the site due to the foreign body in the vagina and need for rehospitalization undergoing spinal anesthesia to attempt to remove the wire, which generates risk to the patient and costs to the hospital.
Additional Manufacturer Narrative
(b)(4).Device history record of batch number 74g1802569 has been reviewed.Nonconformance's were issued for another condition that is not related to the failure mode reported.No corrective action can be implemented due to the lack of product code to perform a proper investigation to determine a root cause.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.
Event or Problem Description
I would like to report a non-conformity related to the capio suture thread (ref: (b)(4).Update: the surgeons described in their report, as follows: since the discontinuation of the supply of absorbable suture thread, where we used sacrospinous fixation for colpus we have had postoperative complications due to the fact that the thread is non-absorbable we have had important granulomas at the site, infectious processes at the site due to the foreign body in the vagina and need for rehospitalization undergoing spinal anesthesia to attempt to remove the wire, which generates risk to the patient and costs to the hospital.
Additional Manufacturer Narrative
Qn#(b)(4).Sample of batch number 74g1802569 product code 833-114 was received without the original packaging and was received on sealed plastic ziplock bag with a disinfected identification.Product code configuration is needle 2n (2 needles) - 36" (suture length).Inside of the ziplock plastic bag received 1 ea of product code 833-114 batch number 74g1802569, the suture has a length of 36 inch and was received with 1 needle and 1 bullet attached at every end.No damage on the needles was detected.Nevertheless, the sutures show signs of manipulation and contamination was detected throughout the suture.Product code configuration is needle 2n (2 needles) - 36" (suture length).The suture has a length of 36 inch and was received with 1 needle and 1 bullet attached at every end.No damage on the needles was detected.Customer complaint cannot be confirmed due to the lack of detail by the costumer.In additional, based on the results of the visual inspection the condition of contamination observe in the sample cannot be generate at the manufacturing process.Manufacturing personnel will be notified of this event for awareness.
Event or Problem Description
I would like to report a non-conformity related to the capio suture thread (ref: (b)(4)).Update: the surgeons described in their report, as follows: since the discontinuation of the supply of absorbable suture thread, where we used sacrospinous fixation for colpus we have had postoperative complications due to the fact that the thread is non-absorbable we have had important granulomas at the site, infectious processes at the site due to the foreign body in the vagina and need for rehospitalization undergoing spinal anesthesia to attempt to remove the wire, which generates risk to the patient and costs to the hospital.

• Brand Name: TEV GN BR 0 TC-43/HR26 2N 36"
• 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: 13334258
• Report Number: 3004365956-2022-00006
• Device Sequence Number: 17399187
• Product Code: GAT
• UDI-Device Identifier: 14026704603876
• UDI-Public: 14026704603876
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021019
• 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,Followup,Followup
• Report Date (Section B): 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2023
• Device Model Number: IPN000859
• Device Catalogue Number: 833-114
• Device Lot Number: 74G1802569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/21/2022; 09/23/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/21/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown