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

Model Number	265716
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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: do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.
Event or Problem Description
It was reported that the balloon of the silicone foley catheter exploded.Additional information has been requested, but not yet received.Per new information received; it was reported that the balloon of the silicone foley catheter burst.No medical intervention was reported.

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9732836
• Report Number: 1018233-2020-01183
• Device Sequence Number: 2401599
• Product Code: EZC
• UDI-Device Identifier: 00801741039591
• UDI-Public: (01)00801741039591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: Lay User/Patient
• Device Model Number: 265716
• Device Catalogue Number: 265716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1