MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 4INX4IN(10.2CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	2083
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: was the sterility of the product compromised? unknown.What is the status of the return sample? the samples are available, and are waiting for the returning sample.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.Please clarify what is meant by the "the surgeon noted the package with air leakage issue." a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.Before use on the patient, the surgeon noted the there was a package air leakage issue.Another device was used to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/23/2021.Additional information: d9, h3, h6.Corrected information d3, g1.Additional information was requested, and the following was obtained: 1.Please clarify what is meant by the "the surgeon noted the package with air leakage issue." it was found that the package seal wasn't intact when it was about to open the package to use it on the patient.Investigation summary: one picture was received for review.Upon visual inspection of the picture, the sales unit box appears to be with some wrinkles on the one side of the packaging.However, no conclusion could be reached as the device was not returned for analysis.The product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened foil of product code 2083 was received for evaluation and opened.Seal was reviewed and no issues were detected related with the customer complaint.No conclusion could be reached as to what may have caused the reported incident.The manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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: d3 and g1.

• Brand Name: SURGICEL SNOW 4INX4IN(10.2CMX10.2CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11566592
• Report Number: 2210968-2021-02720
• Device Sequence Number: 4455274
• Product Code: LMG
• UDI-Device Identifier: 10705031063600
• UDI-Public: 10705031063600
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 06/30/2022
• Device Model Number: 2083
• Device Catalogue Number: 2083
• Device Lot Number: QHB7441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1