MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 1 S/A CTX CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J765D
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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.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.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: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) inside the sterile barrier - are there any photos of the foreign matter available? yes, see below.- is it possible that the foreign material fell into packaging upon opening of device? possible, but not likely appears to be a piece of an insect.Was the product seal on the foil still intact when the package was opened? yes.Will the device be returned for evaluation? if yes please return all relevant packaging material.No- was disposed after pictures taken.- was the procedure completed without any adverse effect to the patient? hard stop was called.Suture removed from sterile field.New sterile field set up, thorough antimicrobial irrigation performed.Please provide the source or name of person providing answers to follow-up questions: myself.(additional images - (b)(4) image 07 apr 2025 (1), (b)(4) image 07 apr 2025 (2)).A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported to the distributor by the customer: during an operation in our or, they encountered the issue below with a suture pack they received from cardinal.It appears to be a bug.The pack was sealed when brought into the operating room.The device was not available for return.There were no adverse reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/2/2025.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.Additional information: h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a winding former with eight strand product code j765d empty out of its packaging, a foreign matter is visible in the image.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: VCL CT BRD VIO 8X18IN 1 S/A CTX 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: 21926358
• Report Number: 2210968-2025-04654
• Device Sequence Number: 8651171
• Product Code: GAM
• UDI-Device Identifier: 10705031042834
• UDI-Public: (01)10705031042834(17)290131(10)UBMRBT
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: J765D
• Device Lot Number: UBMRBT
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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