MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 1 S/A CT-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number 813T

Device Problems Break (1069); Material Frayed (1262); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information provided: package observed without lubricating content.Have you read the instructions for use? yes.Does the instruction or manual clearly describe how to use the medical device? yes.Have you been trained to use? yes.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information * please clarify how many devices present the defect reported.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Note: related events reported on: mw# 2210968-2023-06402, mw# 2210968-2023-06404, mw# 2210968-2023-06405.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.At the time of opening the suture envelope is observed at the time of performing resistance test it breaks when passing through uterine tissue and frays.No reported adverse patient consequences.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received, five unopened samples that pertain to product code.In order to evaluate the condition of the returned samples, the packets were opened and all suture were found lubricated.The swage and attachment area were examined, and it was noted as expected.The sutures were dispensed without problems and examined, along the strand and no issues related to breakage sutures or fraying sutures were observed during the evaluation.Also, a functional test was performed using instron equipment and tensile force was above the minimum requirements.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint # (b)(4).Correction: e 1.Initial reporter country code.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GUT CHR UD 27IN 1 S/A CT-1
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente; dutra, km 154; sao paolo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17686107
• MDR Text Key: 322674347
• Report Number: 2210968-2023-06403
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 813T
• Device Lot Number: AT6770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 74 KG