MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP834G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2025 and suture was used.During an unknown procedure, the needle kept popping off the suture.Case was completed with a like device.No patient harm was reported.Device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/2/2025 h6 component code: g07002 - no device problem found.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.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: please confirm, how many devices demonstrated the alleged deficiency? when did the needles detach or pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? please confirm how many devices are available to be returned for analysis? 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.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).We had 1 suture with deficiency happened during the case when they were passing needle through tissue 2 boxes available for return but some of one was used i sent back the device friday with package slip i was given.It should be there by tomorrow or the next day.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with sixteen representative unopened samples was received for analysis.The complaint sample was not received for evaluation.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 samples.The 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.A functional test was performed using instron equipment and the pull force result was above the minimum 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 18IN 5-0 S/A PC-1 PRM MP
• 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: 21751172
• Report Number: 2210968-2025-03403
• Device Sequence Number: 18208693
• Product Code: GAM
• UDI-Device Identifier: 10705031055711
• UDI-Public: (01)10705031055711(17)290930(10)1032Z9
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: VCP834G
• Device Lot Number: 1032Z9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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