MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A S-14; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J570G
Medical Device Problem Codes	Break (1069); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: according to feedback from sale reps, suture with unsmooth appearance, it looks like suspected waxy substance on the suture surface, and these sutures are very easy to break h3 investigation summary = > the product was returned to ethicon for evaluation.One open box with twelve (12) representative unopened samples was received for analysis.Product code j570g.Additionally, one photo was provided, and it showed a suture.Upon initial inspection of the samples, no damages were observed on the external packets.In order to evaluate the condition of the returned samples, all packets were opened.The sutures were dispensed and examined; it was noted uneven coating along all the strands.Based on the information currently available, uneven coating and/or thick coating was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Expiration date: nov /30/2029.Date of mfg.: dec/10/2024.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.9.Fda correction/ removal reporting no.
Event or Problem Description
It was reported that a patient underwent a strabismus procedure on (b)(6) 2025 and suture was used.According to the doctor's feedback, under the microscope, the suture is very rough, in a flowering state, and not smooth.Changed another one to continue the surgery, the same problem happened.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 18IN 6-0 D/A S-14
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23842434
• Report Number: 2210968-2025-14279
• Device Sequence Number: 15852780
• Product Code: GAM
• UDI-Device Identifier: 10705031041318
• UDI-Public: (01)10705031041318(17)291130(10)1057CH
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: J570G
• Device Lot Number: 1057CH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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