MAUDE Adverse Event Report: Tri-State DE Mexico, S. DE R.L. DE C.V Medline; DBD-CHLORAHEXADINE KIT

Catalog Number	EBSI1784
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: DBD-CHLORAHEXADINE KIT
• Manufacturer (Section D): Tri-State DE Mexico, S. DE R.L. DE C.V; calzada presidente venustiano; carranza #301; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50796085
• Report Number: 3004519921-2026-00085
• Device Sequence Number: 21213683
• Product Code: OXQ
• UDI-Device Identifier: 10653160383086
• UDI-Public: 10653160383086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: EBSI1784
• Device Lot Number: 2024121190
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown