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

Model Number 0168L20

Device Problems Inaccurate Flow Rate (1249); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  Injury  

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 patient was using the foley catheter and it was no longer allowing the urine to flow.The patient had been using catheters for more than 90 days.Per additional information received on 06dec2021, it was reported that the foley catheter was defective and not allowing urine to flow into the drain bag.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "biological deposits".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the 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 patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.15cc balloon: use 20ml sterile water.20cc balloon: use 25ml sterile water.30cc balloon: use 35ml sterile water.40cc balloon: use 45ml sterile water.75cc balloon: use 80ml 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.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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." h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the patient was using the foley catheter and it was no longer allowing the urine to flow.The patient had been using catheters for more than 90 days.Per additional information from cardinal health, it was reported that the foley catheter was defective and not allowing urine to flow into the drain bag.Per customer via phone on (b)(6) 2022, stated that they believed the problem was not with the catheter but with an infection the customer had.It was unknown what medical intervention was given for infection.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13059938
• MDR Text Key: 282622931
• Report Number: 1018233-2021-08306
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017841
• UDI-Public: (01)00801741017841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0168L20
• Device Catalogue Number: 0168L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other