MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 1 S/A SH; SUTURE, NONABSORBABLE, SILK

Catalog Number	K835H
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One unopened sample that pertains to product code k835h, lot aa4803 was received for analysis.Upon initial inspection of the sample, no external damages were observed on the external packet.Pictures of the product received were provided to ethicon raritan to perform a comparison with the artwork in the system.The sample was noted to be according to the manufacturing process.However, the lot number printed (aa4803) does not belong to the product code k835h.Also, the packet contains a foil packet of product code k835h with one needle/suture combination that belongs to silk suture.Besides that, a characterization was performed with the following results: the needles are sales type sh, ½ circle, silver color, (taper point).The suture belongs to diameter 1 silk multifilament¿, length 75 cm, and black color.The diversion product, counterfeit and tampering is confirmed, since the lot number printed pertains to a different product code.Ethicon product was not distributed by an affiliate authorized.The traceability report was not provided.Based on the samples received, the product is confirmed for counterfeit due to the discrepancies found in the labeling and packaging material.For the remaining product experience code, no information is available to confirm the previous ones.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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.- could you please provide the attachments for the products traceability information from edc and rdc? i do not know what you mean by ¿the attachments¿, but we have requested the traceability to sourcing site based upon batch numbers.- how was the product purchased? with support of a third party services provider in venezuela, contact was made with companies / individuals claiming to sell ethicon branded sutures.Subsequently, same third party vendor acquired the products.- is there an indication of how the product was distributed? not at this time, the intent of the investigation is to get to understand illicit trade products route.- is there any indication of the source? all suspect products batch numbers indicate products manufactured by j&j brazil and distributed to several countries in latin america, those do not include venezuela however.- based on the packaging, is there any indication of which market the original genuine product may have come from? yes, definitely the original products come from latin america market, and colombia seems to be the most probably source as it has received / distributed the vast majority of the lots, but at this time there are no hard elements that can assure colombia as the source.- were the device used on a patient? if so, was there any patient consequence? no, none of the products have been used on a patient, those were acquired for investigative purposes only.- device return status.Please document the shipment tracking number: not applicable - please provide the source or name of person providing answers to follow-up questions: regina zamith.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.Before use on the patient, global brand protection latam team has performed a market survey in (b)(6), 10 different non-authorized and suspicious sellers.All products bought are listed below.Please open a product complaint to register the market survey, check products, batches, manufacturing and expiry dates to confirm the suspicious of counterfeit, diversion or tampering.The product was returned to ethicon for evaluation.One unopened sample that pertains to product code k835h, lot aa4803 was received for analysis.Upon initial inspection of the sample, no external damages were observed on the external packet.Pictures of the product received were provided to ethicon raritan to perform a comparison with the artwork in the system.The sample was noted to be according to the manufacturing process.However, the lot number printed (aa4803) does not belong to the product code k835h.Also, the packet contains a foil packet of product code k835h with one needle/suture combination that belongs to silk suture.Besides that, a characterization was performed with the following results: the needles are sales type sh, ½ circle, silver color, (taper point).The suture belongs to diameter 1 silk multifilament¿, length 75 cm, and black color.The diversion product, counterfeit and tampering is confirmed, since the lot number printed pertains to a different product code.Ethicon product was not distributed by an affiliate authorized.The traceability report was not provided.Based on the samples received, the product is confirmed for counterfeit due to the discrepancies found in the labeling and packaging material.For the remaining product experience code, no information is available to confirm the previous ones.There were no adverse consequences reported.Additional information was requested.

• Brand Name: SILK BLK 30IN 1 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: 20855523
• Report Number: 2210968-2024-12888
• Device Sequence Number: 8832008
• Product Code: GAP
• UDI-Device Identifier: 10705031044432
• UDI-Public: 10705031044432
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: K835H
• Device Lot Number: AA4803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• 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