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

Model Number	US751
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 event description: there are holes are showing up in filters after sterile processing.After examining the filters, they had weak spots in them, and when they were processed, they created pin hole sized holes.Reportedly there were unused filters with pin holes as well.
Additional Manufacturer Narrative
Five-hundred (500) samples were provided for technical evaluation.Results of the investigation observed that the samples show holes in processed filters and in thin areas in the unprocessed filters.The returned complaint filters had holes that appeared to have been caused by mechanical damage.Something rubbed or pinched the paper leading to the cut/holes.Based on the investigation findings, the pin holes most likely resulted from handling.As a result, the reported failure could not be confirmed to be a manufacturing related issue.There are no similar complaints against the reported lot number with this error pattern.

• Brand Name: ROUND FILTERS W/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: 21877429
• Report Number: 2916714-2025-00017
• Device Sequence Number: 18093616
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: (01)04038653473731(10)2411001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/09/2025

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: US751
• Device Catalogue Number: US751
• Device Lot Number: 2411001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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