MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 4-0 S/A TF CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP743D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 ug/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.It was reported by a sales rep that, during an unknown pediatric surgery, before opening the package, it was found that the needle tip had been exposed from the sterile package.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 07/19/2021.Additional h-3 summary: visual analysis of the returned sample determined that one sealed sample of product code vcp743 was received for evaluation.As per visual inspection a hole in the foil packet defect could be observed.The visual inspection concluded that the sterile barrier was compromised due to a pin hole was observed on the foil packet and paper lid caused by the tip needle.The hole in the hole in the cavity and incorrect needle park defects have been correlated to the manufacturing process.Based on the information currently available, the hole in the cavity and incorrect needle park were identified during the investigation of the sample received.This product issue will be addressed through inc¿s quality system.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.

• Brand Name: VCL+ VIO 8X18IN 4-0 S/A TF CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12080293
• Report Number: 2210968-2021-05869
• Device Sequence Number: 11743829
• Product Code: GAM
• UDI-Device Identifier: 10705031055230
• UDI-Public: 10705031055230
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 06/03/2021

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: 01/31/2026
• Device Model Number: VCP743D
• Device Catalogue Number: VCP743D
• Device Lot Number: RBMKUK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1