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

Model Number 165820

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2017

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 urine was bypassing the balloon and not draining through the catheter.The balloons were checked weekly by pulling the fluid out of the balloon and checking the volume of the liquid, and then replacing the fluid back into the balloon.Sometimes the volume of the fluid aspirated from the balloon is less than what it should be, and the balloon is not fully inflated.

Event Description

It was reported that urine was bypassing the balloon and not draining through the catheter.The balloons were checked weekly by pulling the fluid out of the balloon and checking the volume of the liquid, and then replacing the fluid back into the balloon.Sometimes the volume of the fluid aspirated from the balloon is less than what it should be, and the balloon is not fully inflated.

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: "bardex® all-silicone foley catheter shaft made entirely of silicone elastomer caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Manufacturer Narrative

The reported event was unconfirmed.Received 1 unopened all-silicone foley catheter for evaluation.Per visual evaluation, no damages or obstructions were observed along the catheter.No manufacturing defects were observed.Per the functional testing, a flow test was performed.The unit is considered acceptable if it drains 250cc of water according to the following flow rate: french size unused used 20 fr 28 sec.Max.Must drain water flowed properly through the funnel of the catheter and without any interruptions or difficulties.The drain was capable to drain the 250cc in 26 seconds.The catheter was found to be within specification.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: "caution: do not aspirate urine through drainage funnel wall.Single use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." 1065, 2199: "nl".

Event Description

It was reported that urine was bypassing the balloon and not draining through the catheter.The balloons were checked weekly by pulling the fluid out of the balloon and checking the volume of the liquid, and then replacing the fluid back into the balloon.Sometimes the volume of the fluid aspirated from the balloon is less than what it should be, and the balloon is not fully inflated.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: BARDEX CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7222125
• MDR Text Key: 98550787
• Report Number: 1018233-2018-00242
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029776
• UDI-Public: (01)00801741029776
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

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: 01/31/2022
• Device Model Number: 165820
• Device Catalogue Number: 165820
• Device Lot Number: NGBN0619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 03/27/2018
• Supplement Dates FDA Received: 02/28/2018; 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1