MAUDE Adverse Event Report: Crosstex International Inc. AESCULAP; Disposable Filter, Reusable Filter

Model Number	MD344
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dealer stated customer reported holes in filter after sterilization.
Additional Manufacturer Narrative
No similar complaints have been recorded for md344, lot: 2602109.Dhr has been reviewed, no discrepancies noted.Image has been provided for review, image shows burn holes lining up with the retention plate.Potential root cause is excess heat/energy being put into the material causing the melt pattern consistent with the areas of highest exposure (vent holes in the sterilcontainer).Not a manufacturing defect.No further action will be taken at this time.

• Brand Name: AESCULAP
• Common Device Name: Disposable Filter, Reusable Filter
• Manufacturer (Section D): Crosstex International Inc.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer (Section G): Crosstex International Inc.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer Contact: katy peterson ; 6789 w. henrietta rd.; rush, NY 14543 ; +1(847)257-4500
• MDR Report Key: 50359552
• Report Number: 1319130-2026-00007
• Device Sequence Number: 17678412
• Product Code: KCT
• UDI-Device Identifier: 14522281506819
• UDI-Public: (01)14522281506819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K941327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: MD344
• Device Catalogue Number: MD344
• Device Lot Number: 2602109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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: Other
• Patient Sex: Unknown