MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® ALL-SILICONE FOLEY CATHETER; SILICONE CATHETER

Model Number	806518
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the silicone foley catheter developed calcification on the outside.The patient went to their physician on (b)(6) 2019 to have the catheter changed.The physician had to send the patient to an out-patient surgical center to remove the catheter because it was too painful.
Event or Problem Description
It was reported that the silicone foley catheter developed calcification on the outside.The patient went to their physician on (b)(6)2019 to have the catheter changed.The physician had to send the patient to an out-patient surgical center to remove the catheter because it was too painful.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8353293
• Report Number: 1018233-2019-00882
• Device Sequence Number: 16693802
• Product Code: EZL
• UDI-Device Identifier: 00801741039188
• UDI-Public: (01)00801741039188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 806518
• Device Catalogue Number: 806518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other