MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 3-0 S/A SH; SUTURE, NONABSORBABLE, SILK

Catalog Number	K832H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/26/2024.H6 component code: g07002 - device not returned.H6 component code: c22 - photo analysis.H6 component code: c22 - confirmed tampered product.H6 component code: c22 - confirmed diversion product.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.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 provide the lot number for the following products (8682, 814, 628, 6585, 786, 746, 14501, 160, 8423 and j316): these batch number were not available.- could you please confirm if the vendor is authorized by jnj? unauthorized vendors.- could you please provide photos of the product? attached - could you please provide the attachments for the products traceability information from edc and rdc? not available.- how was the product purchased? market survey - is there an indication of how the product was distributed? no - is there any indication of the source? no - based on the packaging, is there any indication of which market the original genuine product may have come from? no, there are few cases with colombia regulatory label.- was the device used on a patient? if so, was there any patient consequence? no - device return status.Please document the shipment tracking number: - please provide the source or name of person providing answers to follow-up questions: 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.Photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows six paper lid with printed product code k832, lot number aa1689, the expiration date encoded on the barcode (200331) does not match the printed expiration date (2024-10), indicating that the product has expired and the date does not match our manufacturing records.The low quality of the packaging materials indicated the possibility of tampering and repackaging of the product.Overall the package was confirmed as a tampering product and diversion due to several visible errors.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon 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.Related reports: 2210968-2024-03358, 2210968-2024-04884, 2210968-2024-04885, 2210968-2024-04886, 2210968-2024-04887, 2210968-2024-04888, 2210968-2024-04892 2210968-2024-04889, 2210968-2024-04890, and 2210968-2024-04891.
Event or Problem Description
It was reported from the visual analysis of a photo that the package was confirmed as a tampering product and diversion due to several visible errors.Before use on the patient, on (b)(6) 2024.It was reported that that global brand protection latam team has performed a market survey in venezuela, in valencia, 8 different non-authorized and suspicious sellers.All products bought are listed below.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(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.Corrected information: h6 investigation conclusion (d13-falsified device).

• Brand Name: SILK BLK 30IN 3-0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19195779
• Report Number: 2210968-2024-04922
• Device Sequence Number: 20737160
• Product Code: GAP
• UDI-Device Identifier: 10705031044364
• UDI-Public: 10705031044364
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: K832H
• Device Lot Number: AA1689
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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