MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 1 S/A BP-1; COATED VICRYL* (POLYGLACTIN 910) SUTURE

Model Number	JB645G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.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.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: please provide the lot number: unk.Do you have any photos available for visual analysis? yes, the photos are attached.Please clarify if the product was used in the patient: no.If yes, was there any adverse consequence associated with the patient? na.If the description of the needle is correct with, it seems that the customer intend to use the complaint sample as it is without returning it.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, and strength ¿ = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.Before use on the patient, the surgeon asked the sales rep about changing the product number from jb645 to jb645g, and the appearance of the box.The surgeon commented the following.¿i think the picture of the needle on the box is not a dull needle.Because the description of the dull needle is marked with a circle instead of, please confirm whether the needle inside is correct.¿ no adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/31/2023.H6 component code: g07002 no device returned.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photographs show two boxes with product codes jb645g with lot number phk102 and jb645 with lot number rcmscq both boxes are in accordance with specifications.The finished drawing was compared with the received image and all information was correct.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.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring of complaint information for potential safety signals is conducted through complaint trends as part of post-market surveillance.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.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A BP-1
• Common Device Name: COATED VICRYL* (POLYGLACTIN 910) SUTURE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16383455
• Report Number: 2210968-2023-01143
• Device Sequence Number: 14876498
• Product Code: GAM
• UDI-Device Identifier: 10705031462434
• UDI-Public: 10705031462434
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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,Followup
• Report Date (Section B): 03/31/2023

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: 06/30/2024
• Device Model Number: JB645G
• Device Catalogue Number: JB645G
• Device Lot Number: PHK102
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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