MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER USA - ENDOSCOPIC APPLICATOR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	3123SPEA
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-04375, mw # 2210968-2022-04376, mw # 2210968-2022-04377, mw # 2210968-2022-04379.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.
Event or Problem Description
It was reported that before a patient underwent an unknown procedure on an unknown date, upon arrival the absorbable hemostat applicator was noticed to be unsealed.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Investigation summary = > device history lot = > "a manufacturing record evaluation was performed for the finished device batch sabexl , 3123spea and no non-conformances were identified.Mfg.Date - 1/28/2022 exp.Date - 12/31/2026" product complaint # (b)(4).Corrected information: h3, h6.Component code corrected h3 investigation summary = > the product was returned for evaluation.Visual inspection was conducted on the returned samples.Visual analysis of the returned sample revealed that one bottom overwrap and one surgicel endoscopic applicator of product code 3123spea were returned.The package overwrap was received opened and the top overwrap was not returned for analysis.The seal area of the bottom overwrap was inspected and the seal print evidence could be observed within the perimeter of the overwrap, suggesting that the package was properly sealed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As the complete packaging material was not returned for analysis, it is not possible to determine what caused the reported event.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: d9.Date device returned to manufacturer h3 investigation summary one bottom over wrap and a one surgicel endoscopic applicator of product code 3123spea was returned to ethicon for analysis.In order to evaluate the conditions of the returned sample, the sample was received completely open.For this reason, it was not possible determine if, the applicators were unsealed.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.No conclusion could be reached as to what caused the reported complaint.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: d9.Device available for evaluation, h3, h6.

• Brand Name: SURGICEL POWDER USA - ENDOSCOPIC APPLICATOR
• 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
• MDR Report Key: 14632057
• Report Number: 2210968-2022-04378
• Device Sequence Number: 11740924
• Product Code: LMG
• UDI-Device Identifier: 10705031237513
• UDI-Public: 10705031237513
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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 Model Number: 3123SPEA
• Device Catalogue Number: 3123SPEA
• Device Lot Number: SABEXL
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/08/2022; 06/22/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/14/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown