MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B416
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the return revision of stratafix sutures from the distributor a non-authorized labeling on secondary packaging was noted.The distributor confirm that the products involved were labeling by them.The following data were added by the distributor as part of labeling: storage conditions, sanitary license, lot, qr code and, data importer.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Attempts have been 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.Additional information was requested, and the following was obtained via: how was the product purchased? those products were purchased by johnson & johnson del ecuador to ethicon for official source.Also, the loc sold those products to invimedic.It`s an authorized distributor in ecuador.Seems to be that, invimedic performed a non authorized labeling for our products.That event was escalated to ethicon according our procedures.Is there an indication of how the product was distributed? see answer above please.Is there any indication of the source? see answer above please.Based on the packaging, is there any indication of which market the original genuine product may have come from? see answer above please.Was the device used on a patient? if so, was there any patient consequence? not applicable.There weren´t patient consequences.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.Events reported via: 2210968-2022-04728, 2210968-2022-04730 and 2210968-2022-04731.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 8/29/2022 this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: g07002 no device not returned h6 component code: c22 - photo analysis a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary- photo analysis: this is an analysis of six photos submitted to ethicon for review.During the visual analysis the following was observed: the photos show unauthorized data on the label superimposed on the product boxes.According to the procedures it is a critical defect.As part of our quality process, the manufacturing records for this lot serial number were reviewed and manufacturing standards were met prior to the release of this lot.According to the information currently available, the label shows unauthorized data during the investigation of the received photographs.This product issue will be addressed through ethicon's quality system.Complaint information is additionally tracked for potential safety signals through complaint trends as part of post-market surveillance.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 ¿g/m events reported via: 2210968-2022-04728, 2210968-2022-04729, 2210968-2022-04730 and 2210968-2022-04731.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14761374
• Report Number: 2210968-2022-04729
• Device Sequence Number: 20365490
• Product Code: NEW
• UDI-Device Identifier: 10705031235892
• UDI-Public: 10705031235892
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• PMA/510(K) Number: NA
• 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): 08/29/2022

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 Expiration Date: 07/31/2022
• Device Model Number: SXPP1B416
• Device Catalogue Number: SXPP1B416
• Device Lot Number: QJBASB
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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