MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. AESCULAP; ROUND FILTERS W/INDICATOR

Model Number	US751
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to crosstex for evaluation.No similar complaints have been recorded for us751, lot: 2411001.The dhr (device history record) has been reviewed, no discrepancies noted.The returned complaint filters from the customer had holes that appeared to have been caused by mechanical damage.Potentially the filter retain plate or instruments pressed against the filter inside the sterilcontainer.You can see where something rubbed or pinched the paper leading to the cut/holes.Investigation still ongoing.
Event or Problem Description
Supplier reports holes are showing up in filters.After customer examined these filters, they had weak spots in them, and when they were processed they created pin hole sized holes.Customer found unused filters with pin holes as well.
Additional Manufacturer Narrative
Returned samples were reviewed, thin areas were identified.The returned complaint filters from the customer had holes that appeared to have been caused by mechanical damage.Potentially the filter retain plate or instruments pressed against the filter inside the sterilcontainer.You can see where something rubbed or pinched the paper leading to the cut/holes.Manufacturing, quality, and technical teams are all aware of the complaint.Complaint will be closed as confirmed, not a manufacturing defect.No further action will be taken at this time.

• Brand Name: AESCULAP
• Common Device Name: ROUND FILTERS W/INDICATOR
• 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: 22019959
• Report Number: 1319130-2025-00004
• Device Sequence Number: 13109148
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: US751
• Device Catalogue Number: US751
• Device Lot Number: 2411001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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