MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP427H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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 by the sales rep, that a full box of sutures labeled and expected to be undyed was received in dyed form.The discrepancy was identified upon inspection of the product, indicating a mismatch between the expected product specifications and the items delivered.No patient involvement.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 3/18/2026.H6 component code: g07002 - pending evaluation of returned device.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: * are there photos available for visual analysis? (box and suture).* please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).* 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.No photos.-materials manager.- sent back via fedex yesterday tracking (b)(4).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: 4/10/2026 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.H6 component code: g07002 no device problem found additional information: d9, h3, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one sealed box with thirty-six unopened samples was received for analysis.Product code vcp427h.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were open and each packet contained one strand undyed.This is according to the requirements for product code vcp427h of undyed braided absorbable suture per packet.No evidence of product mix was found during evaluation.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 issues related to missing component or incorrect quantity were noted.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 27IN 3-0 S/A PS-2 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: 24626676
• Report Number: 2210968-2026-02756
• Device Sequence Number: 21071227
• Product Code: GAM
• UDI-Device Identifier: 10705031053151
• UDI-Public: (01)10705031053151(17)300630(10)109T7C
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/18/2026

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: VCP427H
• Device Lot Number: 109T7C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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