MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM BARD LUBRICATH FOLEY; CATHETER, COUDE

Model Number	A800364
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon completion of medication regimen, an attempt was made to remove patient's foley catheter.Only 6 cc's were able to be removed from the foley balloon.Foley continues to function and drain urine.Balloon inflation line cut, but no air would come out of balloon.Balloon ultimately punctured by provider and deflated.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD LUBRICATH FOLEY
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11243233
• Report Number: 11243233
• Device Sequence Number: 2766228
• Product Code: EZC
• UDI-Device Identifier: 00801741073953
• UDI-Public: (01)00801741073953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/21/2020
• Report Date (Section F): 12/21/2020

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: A800364
• Device Catalogue Number: A800364
• Device Lot Number: NGEU3416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/21/2020