MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J548G
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 5/12/2026.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 information: h6 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: ¿ where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?).¿ is it possible that the foreign material fell into packaging upon opening of device? ¿ was the product seal on the foil still intact when the package was opened? response: i have sent the product back to you for investigation.From the report and what i could see, the dried-up foreign material was on the needle body itself.The nurses opened the sealed pack and only saw the foreign material and put the product aside to report it to us.
Event or Problem Description
It was reported on (b)(6) 2026 that foreign body eg plastic or glue (dried) coating large portion of needle surface.Unusable and could have been accidently retained in patient (anterior chamber or under sclera conjunctiva).No patient involvement.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/28/2026 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.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: ¿ where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) ¿ is it possible that the foreign material fell into packaging upon opening of device? ¿ was the product seal on the foil still intact when the package was opened? ¿ please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.¿ please 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) 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.A photo 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.

• Brand Name: COATED VICRYL
• 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: 25020707
• Report Number: 2210968-2026-04591
• Device Sequence Number: 18555571
• Product Code: GAM
• UDI-Device Identifier: 10705031041134
• UDI-Public: (01)10705031041134(17)300630(10)10A0UC
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022269
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: J548G
• Device Lot Number: 10A0UC
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/13/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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