MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X27IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JJ31G
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/20/2025 h6 component code: g07002 - no device problem found.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, 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.Additional information was requested, the following was obtained: - please confirm, in which component was the alleged deficiency (¿.He thought one of his 0 pop-off suture packs were too thin for it being a 0 suture.¿) noticed, suture thread or needle? thread - were there patient consequences? if yes, please explain.Unknown - lot number? unknown - please confirm if a replacement needs to be processed to the account.Yes - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Just received shipping box.Sending by (b)(6).- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6).H3 investigational summary: the product was returned to ethicon for evaluation.One winding former with five unused needle suture combinations were received for analysis.The product code jj31g is multistrand and contains eight strands per packet.To evaluate the condition of the returned sample.The needle suture combinations were dispensed without problems and examined, no anomalies or defects were observed.In addition, the sutures were measured in the federal gauge, and the results met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies on the sutures were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the doctor was concerned about one of the suture packs.He thought one of his 0 pop-off suture packs were too thin for it being a 0 suture.Devices were returning.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 8X27IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21654158
• Report Number: 2210968-2025-02992
• Device Sequence Number: 9276647
• Product Code: GAM
• UDI-Device Identifier: 10705031044111
• UDI-Public: 10705031044111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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 Catalogue Number: JJ31G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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