MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; STERILIZATION WRAP CONTAINER

Model Number	US999
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
As reported by user facility: there was an order of filters #us999 that was observed to have holes upon inspection.No patient involvement.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Eight (8) sample provided were returned to the manufacturing site for technical evaluation.Results of the investigation determined that there were holes present on the filters.However, under microscopic analysis no perforations or fiber discontinuities were observed.The lighter areas were determined to be variations in fiber coloration where the paper web remained continuous and intact.All materials maintained full barrier integrity and mechanical properties.The observed condition was attributed to natural fiber-density variation, visually misinterpreted as holes under certain lighting conditions.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Based on the investigation findings, the product meets specifications.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: AESCULAP
• Common Device Name: STERILIZATION WRAP CONTAINER
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley 48471 9728
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley 48471-9728
• MDR Report Key: 22205757
• Report Number: 2916714-2025-00037
• Device Sequence Number: 6764702
• Product Code: KCT
• UDI-Device Identifier: 04046964910500
• UDI-Public: (01)04046964910500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944864
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Model Number: US999
• Device Catalogue Number: US999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown