MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A V-7 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	D10069
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	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.The following information was requested, but unavailable: it was reported "there was suspected rust on the needle".Was the product seal on the foil still intact when the package was opened? h3 investigation summary: the product was returned to ethicon for evaluation.One open msda packet with ten needle suture combinations was received for analysis.The product code d10069 is multistrand and contains ten strands, double-armed.Upon visual analysis of the returned sample, it was noted that two needles have dark spots, which do not conform to the requirements, as the needles have an incorrect finish.No anomalies were noted for the remaining eighteen needles.Based on the information currently available, an incorrect finish was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a mitral valve replacement procedure on (b)(6) 2025 and suture was used.Before surgery, after unpacking the suture, it was found that there was suspected rust on the needle, and the surface of the needle was not smooth.Changed to another one to continue the surgery, and the same problem happened.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A V-7 10PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 21861975
• Report Number: 2210968-2025-04045
• Device Sequence Number: 15395492
• Product Code: GAT
• UDI-Device Identifier: 10705031134423
• UDI-Public: (01)10705031134423(17)290430(10)1019MG
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• 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
• Report Date (Section B): 04/15/2025

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: D10069
• Device Lot Number: 1019MG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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