MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J496G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: the product is not mixed.The product is correct.See pictures previously sent.The lot # on the pack slip doesn't match the lot on the product.Lot skmklk, exp date 8/31/27 is listed on the pack slip.The lot on the product is slmhuu, exp date 9/30/27.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2022-10628, 2210968-2022-10629, 2210968-2022-10630.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.Before use on the patient, it was reported by the customer that in the receiving department, they discovered that item lot number mismatched of item j496g.When entering into their system, lot number on the item is slmhuu with an expiration of 9/30/2027, but the packing slip and invoice item show lot number as skmklk with an expiration date of 8/31/2027, which is the correct expiration date appearing on the invoice.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.Additional information: h6.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows four boxes with product code j496g with lot number slmhuu expiration date: sep/30/2027.An invoice shows an order for four units with lot number skmklk with expiration date: aug/31/2027.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/15/2023 h6 component code: g07002 no device problem found.H3 investigational summary: visual analysis of the returned sample revealed that it was received four sealed boxes that pertain to product code j496g, lot slmhuu.The lot number was entered into the database and the results were found that the lot slmhuu belongs to product code j496g.It is according to the process specifications and the products were manufactured by ethicon.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.The event described could not be confirmed as the labeling is according to the database.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending 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.Related reports: 2210968-2022-10628, 2210968-2022-10629, 2210968-2022-10630.

• Brand Name: VCL CT BRD UD 18IN 4-0 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: 16051313
• Report Number: 2210968-2022-10631
• Device Sequence Number: 20443514
• Product Code: GAM
• UDI-Device Identifier: 10705031040588
• UDI-Public: 10705031040588
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: J496G
• Device Catalogue Number: J496G
• Device Lot Number: SLMHUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/24/2023; 02/22/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/24/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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