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

Model Number	VCPB340H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on an unknown date and suture was used.After opening the package, there was one vcp711 in the box of vcpb340h.Other packs were vcpb340h.The product number of the box in japan is vcpb340h and it is sold as a kit in japan.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.The following information was obtained: please provide lot number: rkmech.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections: we regularly contact with sales rep about the device returning.No further information will be provided.Attempts have been made to retrieve the device.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.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 g /m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/21/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Component code: g07002 no device problem found.Investigational summary: the product was returned to ethicon for evaluation.Visual analysis of the returned sample determined that it was received an opened folder with three strands partially dispensed.The strands and folder pertain to the product code vcp711.The product is a control release; each packet should contain three strands.The box, packaging, labels, or product related to vcpb340h were not provided.A further investigation was performed and the three previous lots and three posteriors lots to manufacturing lot # rkmech, code vcpb340h were reviewed and none lots were matched with the product code vcp711.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/21/2023.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: our failure analysis lab received the additional product with reference to this complaint, the following product was received: product code: vcp711, lot : unknown.This complaint is for product code vcpb340h.This complaint is that one ¿vcp711¿ was in the box of ¿vcpb340h¿, so the vcp711 was returned.1.Could you please clarify if the additional device belong to this complaint? no.2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.See above.3.If the device was not reported before, please provide more details of device malfunction.Na.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Na.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/7/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 device has been received, however clarification is requested whether the product belongs to this complaint.The following additional information was requested: our failure analysis lab received the additional product with reference to this complaint, the following product was received: product code: vcp711.Lot : unknown.This complaint is for product code vcpb340h.1.Could you please clarify if the additional device belong to this complaint? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.

• Brand Name: VCL+ VIO 27IN 0 S/A CTB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16241553
• Report Number: 2210968-2023-00507
• Device Sequence Number: 6454139
• Product Code: GAM
• UDI-Device Identifier: 10705031056398
• UDI-Public: 10705031056398
• 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,Followup,Followup
• Report Date (Section B): 03/21/2023

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 Expiration Date: 08/31/2026
• Device Model Number: VCPB340H
• Device Catalogue Number: VCPB340H
• Device Lot Number: RKMECH
• 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: 01/07/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 02/10/2023; 02/27/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/07/2023; 02/21/2023; 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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