MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED; BARDIA 2-WAY FOLEY CATHETER

Model Number	123512A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the device was not able to drain urine out.
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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.To deflate catheter balloon.Gently, insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If the tails, contact an adequately trained professional for assistance as detected by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.".
Event or Problem Description
It was reported that the device was not able to drain urine out.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: BARDIA 2-WAY FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8490006
• Report Number: 1018233-2019-01760
• Device Sequence Number: 1767444
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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 Model Number: 123512A
• Device Catalogue Number: 123512A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1