MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	US994
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
According to the complainant small pinholes were found in filters that came from two separate packages of us994 1000-pack filters.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).The samples provided were returned to the manufacturing site for technical evaluation.Results of the investigation determined that there were no defects or damages observed on the product.Based on the investigation findings, the returned product met 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 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: elena reifenstein ; 3773 corporate parkway; center valley, PA 18034 ; 8334251464
• MDR Report Key: 23292960
• Report Number: 2916714-2025-00067
• Device Sequence Number: 4889508
• Product Code: KCT
• UDI-Device Identifier: 04046964930812
• UDI-Public: (01)04046964930812
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/19/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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