MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 5 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	MB66G
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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.H3 investigation summary: the product was returned to ethicon for evaluation.One open sample was received for analysis.The product code is mb66g.Upon initial inspection of the samples, no foreign matter was observed on the sample received.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional information was requested, and the following was obtained via: according to sales feedback on 19/aug/2024 via phone, the correct lot number is "ucmdsh".
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.Before use on the patient, it was reported that it was found that there had been foreign matter when sewing in the surgery.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.There were no adverse consequences reported.Additional information was requested.

• Brand Name: EB EXC GRN 4X30IN 5 S/A V-37
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20180978
• Report Number: 2210968-2024-09438
• Device Sequence Number: 8196146
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: (01)10705031046290(11)240311(17)290228(10)UCMDSH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: MB66G
• Device Lot Number: UCMDSH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown