MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP453H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown animal surgery on an unknown date and suture was used.The vet is seeing a lot of reaction in the animals with the suture.The sutures become infected after about 14 days, the vet suspects that it is due to the milk protein that is in the suture.There were no lasting consequences for the animals.The infected wounds have been disinfected and the animals have been given a course of antibiotics to take home.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/12/2024.H6 component code: g07002 - device not returned.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.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: ¿ did the event occur during one or multiple patient procedures? ¿ what is the total number of procedures? ¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).¿ if this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) additional information was requested, the following was obtained: was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? unknown.Did the suture break post-operatively? yes.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.

• Brand Name: VCL+ VIO 27IN 2-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19730280
• Report Number: 2210968-2024-07140
• Device Sequence Number: 20841281
• Product Code: GAM
• UDI-Device Identifier: 10705031053366
• UDI-Public: (01)10705031053366(11)230711(17)260630(10)THBBTJS0
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: K032420
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 06/30/2026
• Device Catalogue Number: VCP453H
• Device Lot Number: THBBTJS0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• 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