MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 1 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPB725D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 component code: g07002 - device not returned.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, during an unknown orthopedic surgery, the product was used for the wound closure.The customer said that the suture detached as soon as they picked up the needle.This happened three packages in a row, so they took out another package and used it.There was no effect on the surgery.The customer has two boxes of the same lot of product, so they asked the sales rep to replace them all, but since this is not a voluntary recall product, it will be first prepared a report on the malfunction status of products from the same lot (whether the same event is being observed), and the sales rep has asked them to wait for the results and continue using the product as usual until then.It was a control release needle.Another product was used to complete the case.No sample will be returned.There were no adverse consequences to the patient.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/19/2025.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.H6 component code: g07002 pending evaluation of returned device.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: the report on the defective situation of the same lot was immediately prepared and submitted, it was not satisfied.Due to the head nurse being busy scheduled during our appointment today, they requested to investigate the issue and to retrieve all products from the same lot.The head nurse's intentions were already heard from the (b)(6) department beforehand, so the approval was obtained from my superiors, mr.(b)(6) and mr.(b)(6), and retrieved all the products.The head nurse was also explained again about the tendency for the c/r to detach easily and how to use it properly, and they were suggested to hold a proper usage training session in the operating room if the problem persists.Apologize for the inconvenience, but it would be appreciated if investigation could be executed again whether the tendency for it to detach easily is within the standard range.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/10/2025.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.H6 component code: c22 - photo analysis.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Twenty-three (23) representative unopened samples were received for analysis.Product code vcpb725d.The complaint sample was not received for evaluation.In addition, three photographs were provided, and in the first photo it appears that seven (7) unopened aluminum packages are shown, in the second photo a winding former with eight (8) undispensed strands is shown, and in the third photo a suture with needle is shown.Upon initial inspection of the samples, no external damages were evident on the exterior packaging.Following the sampling plan, a visual inspection was conducted on thirteen (13) samples.The packets were opened, and swage and attachment areas appeared as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.The functional test was performed using instron equipment and the pull force result meet with the requirements.The event described could not be confirmed as the device performed without any defect noted.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 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.

• Brand Name: VCL+ UD 8X18IN 1 S/A CTXB CR
• 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: 23310588
• Report Number: 2210968-2025-11929
• Device Sequence Number: 4851835
• Product Code: GAM
• UDI-Device Identifier: 10705031056510
• UDI-Public: (01)10705031056510(17)291231(10)105U8D
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: VCPB725D
• Device Lot Number: 105U8D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/26/2025; 12/07/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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