MAUDE Adverse Event Report: ETHICON INC. VISTASEAL DUAL APPL 3X; FIBRIN SEALANT PREPARATION DEVICE

Catalog Number	VSTAS1E
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned 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.Additional information was requested, and the following was obtained: what is the expiration date labelled on the box? 2023/10/10 what is the expiration date labelled on the product? 2026/10/10 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a fibrin sealant preparation device was used.The expiration on the box is different from the expiration on the product inside the box.There was no patient or procedure involvement.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Corrected information: d 9.Device available for evaluation? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h6 component code: g07002 - pending evaluation of returned device the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained: -what is the expiration date labelled on the box? 2023/10/10 -what is the expiration date labelled on the product? 2026/10/10 attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- was the dual applicator in question apart of a vistaseal kit or the three pack of dual applicators sold independent of the vistaseal kit? 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 Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.Was the dual applicator in question apart of a vistaseal kit or the three pack of dual applicators sold independent of the vistaseal kit? this was part of the three pack sold independent of the vistaseal kit.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 Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned packaging.Visual analysis of the returned sample revealed that three(3) vstas1e devices were returned inside it's package unopened and inside the secondary box.Upon visually inspection of the packaging, the secondary box show the label of the lot: 3419165 with exp: 2023/10/10 and the three(3) has the print of the lot: 3419165 with exp: 2026/10/10 that is the is the correct expiration date.The label on the secondary box has the incorrect expiration date.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.This report is being submitted pursuant to the provisions of 21 cfr part 803.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 Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d4.Primary udi number.Additional information: d4.Expiration date, h 4.Device manufacture date, h6.Type of investigation.A manufacturing record evaluation was performed for the finished device lot.Batch record of vstas1e lot# 3419165: the vstas1e products has tertiary packing, both primary pack and sales carton label printed the expiration date of products.Per the batch record, the manufacturing date is from oct.09th, 2023 ~ oct.10th, 2023.The batch quantity is (b)(4) boxes ((b)(4) pcs).The expiration date for the batch should be oct.10th, 2026.Per the review of the batch record, the actual expiration date for vstas1e lot# 3419165: the expiration date on sales carton label is incorrect (2023-10-10), and it should be 2026-10-10 not the label on the sales carton label¿2023-10-10¿.The expiration date on tyvek lid is correct (2026-10-10).The expiration date printed on sales carton label is actually the manufacturing date.Ethicon has issued external supplier failure investigation report (fir) for nr-0216772 for tessy to complete.This report is being submitted pursuant to the provisions of 21 cfr part 803.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.

• Brand Name: VISTASEAL DUAL APPL 3X
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): TESSY PLASTICS CO. LTD; 509 ren qing road; pudong 20120 1; CH 201201
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22197895
• Report Number: 2210968-2025-06765
• Device Sequence Number: 18448484
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: (01)10705031462533(17)261010(10)3419165
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: BK180287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/31/2025

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: VSTAS1E
• Device Lot Number: 3419165
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 06/20/2025; 07/04/2025; 07/10/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/19/2025; 06/25/2025; 07/07/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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