MAUDE Adverse Event Report: MAGNOLIA MEDICAL TECHNOLOGIES, INC. STERIPATH MICRO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	4005-EN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Steripath has a waste button that allows blood to travel to the waste container first, then to the blood tube.On this product, the water button has already been pushed, meaning unwasted blood would flow into the collection tube.

• Brand Name: STERIPATH MICRO
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): MAGNOLIA MEDICAL TECHNOLOGIES, INC.; 220 w mercer; suite 100; seattle WA 98119
• MDR Report Key: 22436621
• Report Number: 22436621
• Device Sequence Number: 14610502
• Product Code: JKA
• UDI-Device Identifier: 00858366007412
• UDI-Public: (01)00858366007412
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025
• Report Date (Section F): 06/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4005-EN
• Device Catalogue Number: 4005-EN
• Device Lot Number: 108302874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• 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
• Date Report Sent to FDA: 06/30/2025