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

Catalog Number	VCPB725D
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/5/2026 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.Additional information was requested, the following was obtained: · where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?)=>unk · please describe the type of foreign matter that was observed.=>unk · are there any photos of the foreign matter available?=>no have · is it possible that the foreign material fell into packaging upon opening of device?=>unk · was the product seal on the foil still intact when the package was opened?=>unk · please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.=>the device has been received at (b)(6) and will be shipped.Please check rmao.Tracking number : (b)(4).· please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq)=>(b)(6).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 unknown procedure on an unknown date and suture was used.It was reported it was found that there had been dust in the sterile package.The aluminum package has been opened.The product was not used for the patient.It was a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 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.Additional information: h6, d9, h3 h3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one empty foil and one labeled winding former with eight needle suture combination.The product code vcpb725d is multistrand and should contains eight strands per packet.To evaluate the condition of the returned sample, the paper lid was removed.The winding former and needles were examined and no anomalies or issues related to foreign matter could be observed.In addition, the foil packet was examined and no anomalies were found.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.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.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one empty foil and one labeled winding former with eight needle suture combination.The product code vcpb725d is multistrand and should contains eight strands per packet.To evaluate the condition of the returned sample, the paper lid was removed.The winding former and needles were examined and no anomalies or issues related to foreign matter could be observed.In addition, the foil packet was examined and no anomalies were found.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.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.

• 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: 23958872
• Report Number: 2210968-2026-00026
• Device Sequence Number: 5739455
• Product Code: GAM
• UDI-Device Identifier: 10705031056510
• UDI-Public: (01)10705031056510(17)291031(10)104JMJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 104JMJ
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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