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

Catalog Number 165812

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Split (2537)

Patient Problem 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.The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that catheter had fallen out of the patient with a split balloon.Another catheter was put and was also found to have fallen out of the patient with a similar split on the balloon.The times or duration the catheters had fallen out of the patient was unknown.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "for urological use only use a luer tip syringe.Inflate with stated ml of sterile water.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone." (b)(4).

Event Description

It was reported that catheter had fallen out of the patient with a split balloon.Another catheter was put and was also found to have fallen out of the patient with a similar split on the balloon.The times or duration the catheters had fallen out of the patient was unknown.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7167785
• MDR Text Key: 96729157
• Report Number: 1018233-2018-00035
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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: 11/01/2021
• Device Catalogue Number: 165812
• Device Lot Number: MYBQED62
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1