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

Model Number	265718
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: caution states "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." the device was not returned.
Event or Problem Description
It was reported that the balloon of the silicone foley catheter mushroomed; causing pain to the patient.No medical intervention reported.

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8777875
• Report Number: 1018233-2019-03843
• Device Sequence Number: 1904659
• Product Code: EZC
• UDI-Device Identifier: 00801741039607
• UDI-Public: (01)00801741039607
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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 Expiration Date: 10/28/2023
• Device Model Number: 265718
• Device Catalogue Number: 265718
• Device Lot Number: MYCZ4704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1