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

Catalog Number	1758SI18
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, patient started using foley catheter in june, but two of the six balloons the user used burst and had to be removed naturally.The patient was in pain and had some urinary leakage, so when the balloon was replaced and removed, the user found something that looked like a urinary stone stuck to the balloon.It was unknown if the urinary stone caused the balloon to burst.No medical intervention was reported.
Additional Manufacturer Narrative
The complete initial reporter facility name is (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it state.Warnings: 1.Method for use: (1) do not inflate the balloon in the urethra.The urethra may be injured.(2) do not pull the catheter hard.The bladder/urethra may be injured.2.Applicable patients: (1) patients with delirium who might pull out catheter when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.Contraindications: 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).They may damage the device and may burst balloon.(4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.Catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.2.Applicable patients: (1) patients with known allergy to silver coated catheter.Directions for use: 1.Method of use: the device is intended for single use only and is not reusable.1) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2) lubricate the distal end of the catheter with water-soluble lubricant.3) insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.4) pull catheter to seat the balloon at the level of the bladder neck and secure placement.5) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.A dhr could not be performed since no lot number was provided.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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, patient started using foley catheter in june, but two of the six balloons the user used burst and had to be removed naturally.The patient was in pain and had some urinary leakage, so when the balloon was replaced and removed, the user found something that looked like a urinary stone stuck to the balloon.It was unknown if the urinary stone caused the balloon to burst.No medical intervention was reported.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• 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 30014 ; 7707846100
• MDR Report Key: 22628894
• Report Number: 1018233-2025-06181
• Device Sequence Number: 21067060
• Product Code: EZL
• UDI-Device Identifier: 00801741025235
• UDI-Public: (01)00801741025235
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 1758SI18
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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