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	01/26/2025
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.Additional information was requested and the following was provided: please describe the type of 'substance' that was observed.What was the substance's appearance? it appears to be a manufacturing-derived material; however, since it was returned by the manufacturer, further investigation is required for final confirmation please confirm the event and received date.Event date: 26-jan-2025 / received date: 25-nov-2025.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 unknown procedure on (b)(6) 2025 and suture was used.There was undefined substance nearby needle.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/23/2026.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.H6 component code: c22 - photo analysis.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: - please describe the type of 'substance' that was observed.What was the substance's appearance? it appears to be a manufacturing-derived material; however, since it was returned by the manufacturer, further investigation is required for final confirmation - please confirm the event and received date.Event date: 26-jan-2025 / received date: 25-nov-2025 h3 investigational summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle with an unknown substance in the attachment area.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.Three representative unopened samples were received for analysis.The product code u7003 is double armed.Upon initial inspection of the samples, no external damage was observed on the external packets.During evaluation of the returned samples, five needles exhibited excess epoxy in the channel area and nearby the suture; one needle showed no epoxy-related anomalies.Based on the information currently available, excessive epoxy was identified during the investigation of the sample received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• 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: 23888913
• Report Number: 2210968-2025-14578
• Device Sequence Number: 17311309
• Product Code: GAR
• UDI-Device Identifier: 10705031202238
• UDI-Public: (01)10705031202238(17)300228(10)106SZ4
• 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,Followup
• Report Date (Section B): 02/24/2026

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: 106SZ4
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 02/13/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/23/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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