MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y497G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Before use on the patient, it was reported by the sales rep that 'within their suture box of p.C.Y497 was one suture p.C.Y426.After talking with the circulating nurse who discovered the suture in the incorrect box, she admitted it could have been human error on their part of putting suture y426 in the wrong box after a previous case where suture y426 was pulled but not used and simply put in the wrong box.I did discover that they stock both sutures so it is likely the way the y426 end up in a box labeled for y497 by mistake when put back suture not used.Since this was texted into me and since i guess it could be possible ethicon packaged this box incorrectly, i felt it was my duty to submit this possible product complaint.The box of suture labeled for y497 still contained 2 sutures labeled as y497.The lot number for y497 is smmqzu the single suture that was found in box labeled y497 was p.C.Y426.The lot number for y426 is semjde.When the wrong suture was opened and handed to the surgeon he recognized it was the wrong suture immediately and they replaced it with the correct suture with no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4) adverse event problem component code: g07002 - device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is it possible to verify if this was a human error or that it was a mix product issue? could you please confirm.Events reported via: this report and 2210968-2023-01203.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 3/15/2023.A manufacturing record evaluation was performed for the finished device lot, 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 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: 2210968-2023-01204 and 2210968-2023-01203.

• Brand Name: MCRYL UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16391322
• Report Number: 2210968-2023-01204
• Device Sequence Number: 5514549
• Product Code: GAN
• UDI-Device Identifier: 10705031059399
• UDI-Public: 10705031059399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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 Model Number: Y497G
• Device Catalogue Number: Y497G
• Device Lot Number: SMMQZU
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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