MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER

Model Number 0170SI16

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Infection (1930)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient had the catheter in for about a week and it started leaking and caused an infection.It was unknown what medical intervention was given for infection.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to bad fit with the connector.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.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: "visually inspect the product for any imperfections or surface deterioration prior to use.Do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst." the device was not returned.

Event Description

It was reported that the patient had the catheter in for about a week and started leaking which resulted in infection.It is unknown what medical intervention was given to the infection.Per follow up on 20nov2020 the urine was leaking around the foley catheter after about a week of use and caused the patient to develop the infection.The infection was treated with antibiotics and the patient received some latex catheters with no further issues.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10714739
• MDR Text Key: 212454953
• Report Number: 1018233-2020-20298
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025341
• UDI-Public: (01)00801741025341
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0170SI16
• Device Catalogue Number: 0170SI16-BARD
• Device Lot Number: NGET2685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention