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

Catalog Number	165816
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
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 for the second time foley catheter was burst inside the customer; first time the ticket was.Customer had to go to the emergency room and he was bleedings.Foley catheter was placed on (b)(6) 2026 it burst.It was unknown what medical intervention was provided.
Event or Problem Description
It was reported that for the second time foley catheter was burst inside the customer, first time the ticket was.Customer had to go to the emergency room and he was bleedings.Foley catheter was placed on (b)(6) 2026 and (b)(6) 2026 it burst.It was unknown what medical intervention was provided.
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.The reported event is addressed within the labeling as it states: warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Directions for use: 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.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.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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: a, d.Udi format updated with available product information per gudid.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 for the second time foley catheter was burst inside the customer, first time the ticket was.Customer had to go to the emergency room and he was bleedings.Foley catheter was placed on (b)(6) 2026 it burst.It was unknown what medical intervention was provided.Per follow up information received on 27mar2026, it was reported there is physical evidence available.There is a number on the catheter: 165816.Because balloon broke inside my bladder, it came out which required a trip to the er to have another catheter inserted for proper drainage.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 12474528.Visual: received one (1) used 2-way foley catheter without original packaging.Verified material number 165816 and manufacturing lot number ngju1070.Visual inspection noted balloon rupture (measuring 0.3745) on the return sample.Further inspection noted the balloon had no missing pieces.This is out of specification per inspection which states, "balloon must not be torn".Risk review, labeling review, and dhr review are not required as capa 12474528 is applicable for this product lot number.Corrections: d, h.Udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® 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, GA 30014 ; 7707846100
• MDR Report Key: 24206107
• Report Number: 1018233-2026-00436
• Device Sequence Number: 20211031
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752(11)241129(17)270430(10)NGJX3687
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 165816
• Device Lot Number: NGJX3687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 05/01/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/16/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White