MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTER W/O INDICATOR; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	US994
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
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
According to the customer: "we have some filters we are pulling from the bag, inspecting under the light and finding micro pin holes.We removed them from service, grabbed a new bag and have several more we have discovered.We cannot provide the lot information, as this is on the cardboard box and removed prior to coming into spd, as we cannot have cardboard in the department.We had a tray rejected from the or today for the same micro pin hole.This seems to be a manufacture defect issue.".
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Six hundred and twenty samples were returned to the manufacturing site for technical evaluation.Results of the investigation confirmed that micro-holes were observed in the filters.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Retain samples have been reviewed, and the potential for micro-holes have been identified.There are no similar complaints against the reported lot numbers with this error pattern.Based on the investigation findings, the root cause could not be determined.The supplier is a raw material supplier is an international organization for standardization (iso) 13485 certified supplier for sterilization packaging and infection control material and tests each lot of this filter material for porosity, permeability, and water repellency.

• Brand Name: ROUND FILTER W/O INDICATOR
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22237123
• Report Number: 2916714-2025-00035
• Device Sequence Number: 21106931
• Product Code: KCT
• UDI-Device Identifier: 04046964930812
• UDI-Public: (01)04046964930812(10)2503006
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K193582
• 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): 08/12/2025

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: US994
• Device Catalogue Number: US994
• Device Lot Number: 2503006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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
• Patient Sex: Unknown