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

Catalog Number	3013SP
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
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: hair was found after opening the package.It was an orthopedic surgery, and the doctor was wearing a full-body surgical gown, so it was the situation that it was difficult to get in a hair from outside.The following information was requested, but unavailable: where was the hair found? (inside the sterile barrier or outside of the sterile barrier?) inside of the sterile package.Unk.Is it possible that the hair fell into packaging upon opening of device? unk.Was the product seal on the foil still intact when the package was opened? unk.Was the procedure completed without any adverse effect to the patient? unk.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 a patient underwent an orthopedic procedure on (b)(6) 2025 and absorbable hemostat was used.During surgery, it was found there had been a hair inside the sterile package.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h 6.Investigation findings: c22 ¿ photo investigation h3 investigation summary according to the information received, foreign matter inside sterile barrier was reported.The product was returned to ethicon for evaluation.One open pouch with an empty folder packet and one syringe with surgicel powder were received for analysis.Product code 3013sp.During initial inspection, a foreign matter that appears to be hair was found, adhered with adhesive tape inside the folder packet.To complement this assessment, a photograph was provided, visually documenting a foreign matter within the foil pouch.However, given the current condition of the sample, it is not possible to determine the root cause of the reported event.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch, 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.

• Brand Name: SURGICEL POWDER USA - ABSORBABLE HEMOSTA
• 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 PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22907733
• Report Number: 2210968-2025-09894
• Device Sequence Number: 9089279
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: (01)10705031237506(17)260930(10)107KD3
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 09/30/2026
• Device Catalogue Number: 3013SP
• Device Lot Number: 107KD3
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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