MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC AESCULAP; ROUND PRINTED FILTERS, 7.5"

Model Number	US751
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Similar complaints have been recorded for us 751 within the past year.Unable to review dhr and retention samples without lot code information.Product was returned for review, the brown staining appears in a spiral pattern with varying levels of saturation.This is inconsistent with indicator ink, either printed or sprayed.Potential root cause, staining is either influences or caused by the pressurized steam in the sterilizer vessel staining the exposed filter during a vacuum or exhaust phase.Complaint will be closed as not confirmed, not a manufacturing defect.No further action will be taken at this time.
Event or Problem Description
Customer has concern about brown staining on filters.This incident occurred on (b)(6) 2026 and caused a delay to a case.Approximately (3) filters showed the brown stains.

• Brand Name: AESCULAP
• Common Device Name: ROUND PRINTED FILTERS, 7.5"
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC; 6789 w. henrietta road; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL INC; 6789 w. henrietta road; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w. henrietta road; rush, NY 14543
• MDR Report Key: 25470343
• Report Number: 1319130-2026-00005
• Device Sequence Number: 10465915
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: (01)04038653473731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K890765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown