MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. AESCULAP; 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	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Supplier reported that filters were shredded.
Additional Manufacturer Narrative
The device subject of the reported event was returned to crosstex for evaulation.Investigation is still ongoing.
Additional Manufacturer Narrative
No similar complaints have been recorded for md344, lots 2503102 & 2501102.Dhr has been reviewed, no discrepancies noted.Retention samples have been reviewed, no discrepancies noted.Unable to determine a potential root cause as this is not a manufacturing defect and occurred post-sterilization.No further action will be taken at this time.

• Brand Name: AESCULAP
• Common Device Name: 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 ; 8472574500
• MDR Report Key: 22172001
• Report Number: 1319130-2025-00005
• Device Sequence Number: 12720090
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 2501102, 2503102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (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