MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP317H
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
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, 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.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: confirm the products lot number: it is not available could you please confirm if the vendor is authorized by jnj? it is not authorized.Could you please provide the attachments for the products traceability information from edc and rdc? na.How was the product purchased? incident was reported by the hospital, no details about the purchase.Is there an indication of how the product was distributed? no.Is there any indication of the source?no.Based on the packaging, is there any indication of which market the original genuine product may have come from? no.Was the device used on a patient? if so, was there any patient consequence? it was verified by the physician when it was open the packaging material.Device return status.Please document the shipment tracking number: no.Please provide the source or name of person providing answers to follow-up questions: photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photos show four open aluminum packages with product code vcp317 2-0 with winding former inside with product code vcp316 3-0.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 instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of quality process all devices are manufactured, inspected, and released to approved specifications.Events reported via: 2210968-2023-08383, 2210968-2023-08384, 2210968-2023-08385, 2210968-2023-08387.
Event or Problem Description
It was reported that a patient underwent an unknown procedure (b)(6) 2023 and suture was used.Before use on the patient, it was found in the city of barquisimeto a complaint where they bought a 2-0 vicryl for a surgery performed on friday, (b)(6) according to the envelope, and when they open the envelope in the operating room, the blister that comes inside is 3-0 vicryl, the envelope it is visibly a fake, the 3-0 blister seems real, however we assume that it is expired and they insert it into supposedly valid envelopes (we attach photos).No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18040698
• Report Number: 2210968-2023-08383
• Device Sequence Number: 20886374
• Product Code: GAM
• UDI-Device Identifier: 10705031052253
• UDI-Public: 10705031052253
• Combination Product (Y/N): Y
• Initial Reporter Country: VE
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: VCP317H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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