MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number	A319414AM
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After visual inspection of the device, the device was inserted into the patient.Approximately 20 minutes after, urine began to collect into the bag, the bag began to leak onto the floor.The device had to be removed and another device placed using sterile technique.The device was retained for investigation; however packaging was discarded.There is no known negative impact to the patient.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7705916
• Report Number: 7705916
• Device Sequence Number: 1511053
• Product Code: MJC
• UDI-Device Identifier: 00801741073854
• UDI-Public: (01)00801741073854
• 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): 07/17/2018
• Report Date (Section F): 07/17/2018

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: No Information
• Device Model Number: A319414AM
• Device Catalogue Number: A319414AM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2018