MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A TG100-8; SUTURE, ABSORBABLE, NATURAL

Model Number	J544G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure (b)(6) 2022 and suture was used.Before use on the patient, it was reported that it was not possible to read the qr code on the suture packaging.It was noted that the problem was not with the reader, but in the quality of printing the qr code.No adverse patient consequences were reported.Additional information was requested.
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.Events reported via: 2210968-2022-07956, 2210968-2022-07962, 2210968-2022-07965, 2210968-2022-07966, 2210968-2022-07967, 2210968-2022-07971, 2210968-2022-07947, 2210968-2022-07948, 2210968-2022-07949, 2210968-2022-07950, 2210968-2022-07981, 2210968-2022-07982, 2210968-2022-07984, 2210968-2022-07985, 2210968-2022-07986, 2210968-2022-07987, 2210968-2022-07988, 2210968-2022-07989, 2210968-2022-07990, 2210968-2022-07991.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/7/2022 this is a combination product, and the event has been reviewed for both the suture and the triclosan.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.H6 component code: g07002 no device returned 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: code j603h correct lot: sbmcud 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.Related reports: 2210968-2022-07956, 2210968-2022-07962, 2210968-2022-07965, 2210968-2022-07966, 2210968-2022-07967, 2210968-2022-07971, 2210968-2022-07947, 2210968-2022-07948, 2210968-2022-07949, 2210968-2022-07950, 2210968-2022-07981, 2210968-2022-07984, 2210968-2022-07985, 2210968-2022-07986, 2210968-2022-07987, 2210968-2022-07988, 2210968-2022-07989, 2210968-2022-07990, 2210968-2022-07991.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 10/4/2022 additional information: d4, g1, h4 additional information was requested, the following was obtained: lot numbers for: cf810t- lot ar7893 sxpp1b410- lot rpbaph sxpp1b405-lot rmbeba j571g- lot ar2693 xyj303h- lot ar0401 sxpp1b415- lot rkbadj j603h- lot 5bmcvd xyj341h - lot ap5547 sxpp1b420- lot sabddl xyj544g- lot ap4710 sxpp1b450- lot rmbbeb xyj375h- lot- ar4188 sxmp1b409- lot- rlbjaq z316h- lot- rlmadt j353h.Un- lot - ar8573 device return status? not available.The following additional information was requested: please confirm the lot for product code xyj303h is ar0401 please confirm the lot for product code j603h.5bmcvd is not a valid lot.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.Product complaint # (b)(4) date sent to fda: 10/4/2022 corrected information: d1, d2a, d4 (product code) 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: VCL CT BRD VIO 18IN 6-0 D/A TG100-8
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15499699
• Report Number: 2210968-2022-07982
• Device Sequence Number: 14882097
• Product Code: GAM
• UDI-Device Identifier: 10705031041073
• UDI-Public: 10705031041073
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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: 02/28/2026
• Device Model Number: J544G
• Device Catalogue Number: J544G
• Device Lot Number: AP4710
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/03/2022; 10/27/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/04/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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