MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B415
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 barbed 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 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.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.Trade name irgacare®.Active ingredient(s) triclosan.Dosage form suture/solid/parenteral.Strength ¿ = 2360 g/m.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, 2210968-2022-07991.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/4/2022.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.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.Events reported via: 2210968-2022-07965, 2210968-2022-07966, 2210968-2022-07967, 2210968-2022-07971, 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, and 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.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 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, 2210968-2022-07982, 2210968-2022-07984, 2210968-2022-07985, 2210968-2022-07986, 2210968-2022-07987, 2210968-2022-07988, 2210968-2022-07989, 2210968-2022-07991.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15499644
• Report Number: 2210968-2022-07990
• Device Sequence Number: 5181586
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K150670
• 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: 08/31/2023
• Device Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Device Lot Number: RKBADJ
• 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: 09/01/2021
• 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