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

Catalog Number 123520

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

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

Event Date 12/29/2018

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 catheter fell out of the patient on the second day after placement.

Event Description

It was reported that the catheter fell out of the patient on the second day after placement.

Manufacturer Narrative

Evaluation found no leakage on the returned catheter.The catheter had undergone 7 days leak test and no leakage was observed on the catheter.The catheter was dissected and found no conditions that could have contributed to the reported event.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: "[contraindications/prohibitions] -concerning use 1) do not reuse.2) the balloon and shaft of catheter should not be pinched with forceps, etc.Damage to the catheter with a blade or sharp-edged devices must be avoided.[there is a strong likelihood that breakage or spontaneous removal of catheter, or rupture balloon will occur, and that inability of balloon to deflate may make removal of the catheter difficult.] [prohibited concomitant use] 1) do not use ointments, contrast medium or lubricants having a petrolatum base on catheter (including oil of animal or plant origin, such as olive oil and petrolatum jelly and mineral oil).[they will damage latex and may cause balloon to burst.Do not wipe catheter surface with organic solvents (such as alcohol).] 2) no substance except sterile water should be used to inflate the balloon.[the contrast medium may cause balloon to burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.When air is used, air may escape to cause spontaneous deflation of the balloon so that the catheter may come out prematurely.]".

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8285960
• MDR Text Key: 134411058
• Report Number: 1018233-2019-00465
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 123520
• Device Lot Number: 8DR7134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1