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

Model Number 806524

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the catheter was clogged in the part that was inside the body.

Event Description

It was reported that the catheter was clogged in the part that was inside the body.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿blocked lumen¿ with a potential root cause of ¿biological deposits¿.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9343919
• MDR Text Key: 174624524
• Report Number: 1018233-2019-07413
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741039218
• UDI-Public: (01)00801741039218
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 806524
• Device Catalogue Number: 806524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1