MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A X-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP458H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/8/2025.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.Additional information was requested, the following was obtained: ¿ is there evidence that could suggest that the reported devices were part of a product mix in the packages? it is from the same box with same item code.¿ any photos available for visual analysis? attached photo for your reference.¿ please provide the lot number.Ujbbrhb0.¿ please provide with the shipping status and shipment tracking details.We did not ship it (do you need to ship the remaining qty from the same box).¿ 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) (ot nurse).The following information was reported: was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences no patient involvement.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study unknown.(b)(4).Device property of none.Device in possession of none.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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.
Event or Problem Description
It was reported that a patient underwent an abdominoplasty procedure in (b)(6) 2025 and suture was used.It was reported that the needle size is not correct.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/15/2025.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, d9, h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/10/2025.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: g07002 no device problem found.H6 component code: c22 - photo analysis.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Two unopened samples were received for analysis.Product code vcp458h.To evaluate the condition of the returned sample, the packets were opened.The needles were examined, and no anomalies or defects were noted.Additionally, the needles were measured and compared against the specification to detect any issues related to product mix or incorrect component and no issues were observed.The needle meets the finished good specification.To complement this analysis, a photo was provided showing two paper lid and two winding former on the surgical table.A functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the needle meets the needle specification.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 X-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22748398
• Report Number: 2210968-2025-09196
• Device Sequence Number: 18528632
• Product Code: GAM
• UDI-Device Identifier: 10705031078277
• UDI-Public: (01)10705031078277(17)270731(10)UJBBRHB0
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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: VCP458H
• Device Lot Number: UJBBRHB0
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 09/26/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/15/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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