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

Catalog Number	0168L20
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foley catheter did not inflate.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that foley catheter did not inflate.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: bardex lubricath foley catheter the clinical benefits of bardex lubricath indwelling foley catheters are that they aid in clinical management by allowing for continuous drainage and measurement of urine, and when applicable, bladder irrigation and hemostasis.The hydrogel coating is designed to reduce friction in catheter insertion.Foley catheters can be used in patients of all ages.Up to 10 ch/fr is generally considered pediatric sizing; however, the appropriate size should be determined by the healthcare professional.Indications for use: bardex lubricath foley catheters are indicated for use in the drainage and or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.Intended user: this product is intended to be used by qualified healthcare professionals.Intended use: for urological use only.Contraindications: no known contraindications.Warnings: do not use ointments or lubricants having a petroleum base.They will damage catheter and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and or essential material and design characteristics of the device, which may lead to device failure, and or lead to injury, illness, or death of the patient.Users and or patients within the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and or patient is established.Do not use device if package is opened or damaged.Do not aspirate urine through the drainage funnel wall.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Cautions: this product contains natural rubber latex which may cause allergic reactions.Federal law (usa) restricts this device to sale by or on the order of a licensed healthcare practitioner.Storage: keep away from sunlight.Instructions for use: follow your facility protocol for all processes related to catheterisation, re catheterisation, stabilization and urine collection.Follow aseptic procedures outlined by your local hospital or healthcare facility.Thoroughly wash hands, wear sterile gloves, and use aseptic technique whenever handling the catheter or catheter components during insertion.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22231142
• Report Number: 1018233-2025-04645
• Device Sequence Number: 15458554
• Product Code: EZC
• UDI-Device Identifier: 00801741017841
• UDI-Public: (01)00801741017841
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0168L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown