MAUDE Adverse Event Report: C. R. BARD, INC. BARD® FOLEY CATHETER SILICONE COATED; CATHETER, COUDE

Model Number	265718
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was in surgery.A foley catheter was placed during surgery.One day post-op, the patient rolled over, heard a "pop", and the foley catheter came out.The surgeons looked at the catheter and reported it having a split in it.It was sent to clinical engineering for investigation and will be returned to the manufacturer for failure analysis.Per site reporter: the manufacturer will be sending a return kit.The device will be returned for failure analysis.

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 7074297
• Report Number: 7074297
• Device Sequence Number: 927562
• Product Code: EZC
• UDI-Device Identifier: 00801741039607
• UDI-Public: (01)00801741039607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/17/2017
• Report Date (Section F): 11/17/2017

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 Model Number: 265718
• Device Catalogue Number: 265718
• Device Lot Number: NOT RECORDED BY STAFF
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 85
• Date Report Sent to FDA: 11/17/2017