MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP947H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 pp2ahh and no non conformances/ manufacturing irregularities related to the malfunction were identified.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.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.Was there any patient consequences.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 275 g/m.Notes: event reported via mw# 2210968-2021-01329.
Event or Problem Description
It was reported that the patient underwent cabg procedure on (b)(6) 2021 and suture was used.The suture broke while knotting.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 03/15/2021.Additional h6 component code: g07002 ¿ device not returned.Additional information was requested and following was obtained: was there any patient consequences? - no patient consequences.Attempts are being made to clarify 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.Device return follow up status? 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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.

• Brand Name: VCL+ UD 36IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11315925
• Report Number: 2210968-2021-01328
• Device Sequence Number: 715558
• Product Code: GAM
• UDI-Device Identifier: 10705031056169
• UDI-Public: 10705031056169
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 11/30/2024
• Device Model Number: VCP947H
• Device Catalogue Number: VCP947H
• Device Lot Number: PP2AHH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1