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

Model Number 365718

Device Problems Nonstandard Device (1420); Positioning Problem (3009)

Patient Problems No Patient Involvement (2645); 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.

Event Description

It was reported that the balloon of the hydrogel foley catheter was off center when inflated during pre-testing.

Manufacturer Narrative

The reported issue was found to be inconclusive.The photo of the device was found to be inadequate to perform an investigation.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: ¿do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.".

Event Description

It was reported that the balloon of the hydrogel foley catheter was off center when inflated during pre-testing.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Type of Device: HYDROGEL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8268813
• MDR Text Key: 133835787
• Report Number: 1018233-2019-00360
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2021
• Device Model Number: 365718
• Device Catalogue Number: 365718
• Device Lot Number: MYAZR038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1