MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A FS; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	664H
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
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.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 via: - was the product used on the patient? no.- where was the issue identified ? at healthcare facility.- was the issue identified at j&j warehouse ? no.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on the patient, it was reported that a mismatch of rfid tag.The code 664h had the tag of code el5ml was noted on the packaging.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/8/2022.H6 component code: g07002 no device returned.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary - photo analysis: visual analysis of the individual image sent to ethicon for evaluation determined that a closed box of ethilon 664h product could be observed, on the outside a label on the plastic packaging, the label is not part of the ethicon product.As part of our quality process, manufacturing records were reviewed for this lot's serial number and manufacturing standards were met prior to the release of this lot.No conclusion could be reached as to the cause of the reported complaint, as the sample was not returned for analysis.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional information about complaints is tracked for potential safety signals through complaint trends 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 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.

• Brand Name: ETHLN BLK 18IN 2-0 S/A FS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14696214
• Report Number: 2210968-2022-04551
• Device Sequence Number: 5176637
• Product Code: GAR
• UDI-Device Identifier: 10705031007826
• UDI-Public: 10705031007826
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 07/08/2022

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: 09/30/2026
• Device Model Number: 664H
• Device Catalogue Number: 664H
• Device Lot Number: RLBHRM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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