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

Model Number	A303314A
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical manager observed leaking indwelling foley catheter.Catheter was inspected to determine source of leak.Foley catheter bag with urimeter.Leak noted to be from urimeter at green spout.When spout was turned to closed position, spout was not fully catching in threads causing foley to leak.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARDEX IC COMPLETE CARE®
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 605 n 5600 w; salt lake city UT 84116
• MDR Report Key: 7218382
• Report Number: 7218382
• Device Sequence Number: 140518
• Product Code: MJC
• UDI-Device Identifier: 00801741073786
• UDI-Public: (01)00801741073786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2018
• Report Date (Section F): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: A303314A
• Device Catalogue Number: A303314A
• Device Lot Number: NGBX4404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2018
• 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: 01/17/2018