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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hub of iv catheter noted to be cracked resulting in blood leaking from hub and patient had to be stuck again for iv access.

• 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: 20223677
• Report Number: 20223677
• Device Sequence Number: 12636052
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 05/20/2024

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 Model Number: SP125-26-19T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• 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: 05/20/2024