MAUDE Adverse Event Report: TOGO MEDIKIT CO.,LTD. SUPERCATH 5; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	SP125-26-19T
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pt has difficult venous access and needed an us [ultrasound] iv placed.This rn found very few veins, 2 including the brachial.Decided not to stick the brachials d/t [due to] potential need for a picc [peripherally inserted central catheter].This rn stuck the only other vein obvious on us.Iv successful but the area the extension screws onto snapped when the extension was screwed on.This resulted in the iv needing to be removed.

• Brand Name: SUPERCATH 5
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TOGO MEDIKIT CO.,LTD.; 2500 bee cave rd; bldg. 1, ste. 300; austin TX 78746
• MDR Report Key: 22166758
• Report Number: 22166758
• Device Sequence Number: 18492149
• Product Code: FOZ
• UDI-Device Identifier: 04543527241670
• UDI-Public: (01)04543527241670
• 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): 06/04/2025
• Report Date (Section F): 06/04/2025

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: SP125-26-19T
• 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: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• 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 Age: 5 MO
• Patient Sex: Female
• Date Report Sent to FDA: 06/04/2025