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

Model Number 123518A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.However, the potential root cause for this failure mode could be user related (example: salt accumulation)/ blocked drainage lumen/no drainage eye.].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: on catheter, do not use ointments or lubricants having petroleum base.They will drainage latex and cause balloon to burst.Storage.Store catheters at room temperature.".

Event Description

It was reported that the foley catheter did not flow.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12236059
• MDR Text Key: 263832707
• Report Number: 1018233-2021-04560
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095108
• UDI-Public: (01)00801741095108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 123518A
• Device Catalogue Number: 123518A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other