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

Catalog Number 123514A

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); 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 07/18/2019

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 when draining urine for this patient on july 17, the physician used paroline as lubricant and injected 8 ml of normal saline.During patient nursing in the morning of the following day, a nurse observed the urethral catheter was detached with the balloon ruptured.A check revealed that the edges of the fractured balloon were complete.It was replaced with a new urethral catheter.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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: do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not re-sterilize.For urological use only.Before using, please inspect visually whether products are all complete or surface wear." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that when draining urine for this patient on (b)(6) , the physician used paroline as lubricant and injected 8 ml of normal saline.During patient nursing in the morning of the following day, a nurse observed the urethral catheter was detached with the balloon ruptured.A check revealed that the edges of the fractured balloon were complete.It was replaced with a new urethral catheter.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Type of Device: BARDIA FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9672741
• MDR Text Key: 183949207
• Report Number: 1018233-2020-00816
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 123514A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1