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	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr and retention samples are not able to be reviewed without lot code information.Samples were returned, 4 out of the 5 were post-sterilization.The one that was pre-sterilization showed a weak spot not a pinhole.The raw material supplier is iso 13485 certified supplier for sterilization packaging and infection control material and tests each lot of this filter material for porosity, permeability, and water repellency.Review of product requirements are ongoing by both aesculap and hu-friedy's technical teams.Complaint will be closed as not confirmed.
Event or Problem Description
Distributor stated customer reported that filters have been noted to have pin prick holes in the filters.The lot is not known as it is unclear when the processing of the devices occurred - lot therefore cannot be determined based on stock.

• 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: 25317386
• Report Number: 1319130-2026-00004
• Device Sequence Number: 10002644
• 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
• Report Date (Section B): 05/28/2026

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: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• 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