MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; MTO,3V,COMP,KIT,TWEESTEDEN,ZIEKENHUIS

Catalog Number	65620934
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: MTO,3V,COMP,KIT,TWEESTEDEN,ZIEKENHUIS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glens falls technical pk. d; glens falls NY 12801 3864
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25817985
• Report Number: 3015910259-2026-00149
• Device Sequence Number: 12281030
• Product Code: OEZ
• UDI-Device Identifier: 10193489064100
• UDI-Public: 10193489064100
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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 Catalogue Number: 65620934
• Device Lot Number: 0000099540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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