MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A TG140-8; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	7718G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/18/2025 h6 component code: c22 - photo analysis 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.Additional information was requested, the following was obtained: could you please provide the attachments for the products traceability information from edc and rdc? please see attached answer regarding the batch and images with counterfeit elements identified.- how was the product purchased? - is there an indication of how the product was distributed? - is there any indication of the source? - based on the packaging, is there any indication of which market the original genuine product may have come from? - were the devices used on a patient? if so, was there any patient consequence? - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided - please provide the source or name of person providing answers to follow-up questions: images were received for review.Photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During visual analysis the following was observed: a file with two photos and a drawing of the sales unit label with product codes 7718 g, packing information from lot ajs534 was received.Visual inspection of the photographs revealed multiple discrepancies in the labelling, counterfeit items were identified: variable data printed on the front of the package; this printing method is not used for genuine sutures.For your reference: the lot number provided belongs to mersilene®, a different brand of j&j sutures manufactured in 2017.The sales team is currently arranging for samples to be returned.For your reference: the batch number provided belongs to mersilene®¿a different brand of j&j sutures¿manufactured in 2017.As part of our quality process, the manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring of complaint information for potential safety signals will be conducted through complaint trends as part of post-market surveillance.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.The following information was received: ¿ after completing the form, we requested that the warehouse collect the "defective" product and exchange it for other units.¿ upon receiving the "defective" sutures, it was evident that the product was not ours.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an eye procedure on (b)(6) 2025 and suture was used.The needle failed when it penetrated the eye.It was dull.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b1, h1 - it was reported that this device event is not malfunction reportable.Therefore, this medwatch report is not reportable.

• Brand Name: ETHLN BLK 12IN 10-0 D/A TG140-8
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23582401
• Report Number: 2210968-2025-12931
• Device Sequence Number: 13138028
• Product Code: GAR
• UDI-Device Identifier: 10705031010529
• UDI-Public: 10705031010529
• Combination Product (Y/N): N
• Initial Reporter Country: BL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 7718G
• Device Lot Number: AJ8534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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