MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS140-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	U7003
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) 2.Please describe the type of foreign matter that was observed 3.What was the foreign matter¿s appearance? 4.What was the texture? 5.Are there any photos of the foreign matter available? 6.Is it possible that the foreign material fell into packaging upon opening of device? 7.Was the product seal on the foil still intact when the package was opened? 8.Will the device be returned for evaluation? if yes please return all relevant packaging material.Furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.9.Please provide the source or title of external person providing answers to follow-up.Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unspecified procedure on (b)(6) 2025 and suture was used.The facility discovered a foreign substance in the thread.Therefore, they have discontinued use and returned all products from the same lot number.The foreign substance was so small that it could only be detected with a microscope.The product was intended for ocular use.The procedure was successfully completed without delay.There was no patient consequences identified when this complaint event was captured.
Additional Manufacturer Narrative
Product complaint #(b)(4).Corrected information: d 9.Device available for evaluation? h 3.Device evaluated by manufacturer? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer? h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions c22 ¿ photo evaluation.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection revealed that one needle suture piece insert in the foam park was received for analysis.The product code u7003 is double armed.During the visual inspection of the needle, the closure channel was noted to be as expected.However, an excess of epoxy was observed on the swage area.Additionally, the suture piece was examined and the end was noted to be cut likely cause by a surgical instrument.Three photos were provided showing one needle suture insert in a foam park and one sealed box for product code u7003.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.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: ETHLN BLK 12IN 10-0 D/A CS140-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24061556
• Report Number: 2210968-2026-00445
• Device Sequence Number: 9856183
• Product Code: GAR
• UDI-Device Identifier: 10705031202238
• UDI-Public: (01)10705031202238(17)300630(10)109Z7E
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: U7003
• Device Lot Number: 109Z7E
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2025
• 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
• Patient Sex: Unknown