MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP INTERMITTENT CATHETER TRAY; CATHETER, UROLOGICAL

Model Number	INTS16
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After removing straight catheter from patient, the staff brought catheter to the trash and catheter spontaneously disconnected from teal hub on catheter bag, ejecting urine on staff's chest and neck area.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16484891
• Report Number: 16484891
• Device Sequence Number: 20248845
• Product Code: KOD
• UDI-Device Identifier: 00801741183225
• UDI-Public: (01)00801741183225
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/09/2023
• Report Date (Section F): 02/09/2023

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: INTS16
• Device Catalogue Number: INTS16
• Device Lot Number: PK7646931
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/09/2023