MAUDE Adverse Event Report: ETHICON INC. SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	1946
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before opening the package of absorbable hemostat on an unknown date, it was that the perforation of the box was torn, and the sterile package was opened.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned 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: what is the lot number? sje1261 please clarify, how many of the 10 individual products within the sales unit box were found to be opened/unsealed? this issue is related to the outer box.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, 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 Manufacturer Narrative
Product complaint # (b)(4).Additional information: d 9.Device available for evaluation?, h 3.Reason for non- evaluation, h 4.Device manufacture date, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.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, 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.Corrected information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 3.Device evaluated by manufacturer?.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6.Investigation findings: c22 ¿ photo investigation.Photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show one opened box that pertains to product code 1946.No conclusion or root cause could be determined.As part of the ethicon endo surgery quality process, all devices are manufactured, inspected, and released to approved specifications.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, 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 Manufacturer Narrative
Product complaint # (b)(4).Additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample revealed that one opened box that pertains to product code 1946 was returned for analysis.In order to evaluate the conditions of the returned sample, the main tab of the box is fully open.Due to the condition box, a possible cause for this condition is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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, 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.Corrected information: h 3.Device evaluated by manufacturer?.

• Brand Name: SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16768684
• Report Number: 2210968-2023-02817
• Device Sequence Number: 19617839
• Product Code: LMG
• UDI-Device Identifier: 10705031002999
• UDI-Public: 10705031002999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2023

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: 1946
• Device Catalogue Number: 1946
• Device Lot Number: SJE1261
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 05/12/2023; 05/18/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/03/2023; 05/15/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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