MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM BARD ALL SILICONE FOLEY CATHETER TRAY; CATHETER, URETHRAL

Model Number	A897214
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rnfa was checking a foley balloon prior to insertion and the balloon would not deflate unless direct pressure was applied to the balloon.Bard foley tray system.Ref (b)(4).We opened another catheter and used it.No pt/emp harm.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD ALL SILICONE FOLEY CATHETER TRAY
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8008705
• Report Number: 8008705
• Device Sequence Number: 18874284
• Product Code: GBM
• UDI-Device Identifier: 00801741104497
• UDI-Public: (01)00801741104497
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 10/16/2018
• Report Date (Section F): 10/16/2018

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: Health Professional
• Device Model Number: A897214
• Device Catalogue Number: A897214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2018
• 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: 10/16/2018