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	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dealer reported that the filters keep coming out with holes on them.The holes are from the lid.The lid seems to be imprinting on the filter.
Additional Manufacturer Narrative
No similar complaints have been recorded for md344, lot 2508104.Dhr has been reviewed, no discrepancies noted.Returned samples show, holes that were made post sterilization.Post sterilization holes do not appear to be related to the manufacturing process.

• 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: stephanie wasielewski ; 6789 w. henrietta rd.; rush, NY 14543
• MDR Report Key: 23707695
• Report Number: 1319130-2025-00012
• Device Sequence Number: 10691738
• Product Code: FRG
• UDI-Device Identifier: 14522281506819
• UDI-Public: (01)14522281506819
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: MD344
• Device Catalogue Number: MD344
• Device Lot Number: 2508104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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