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

Catalog Number	165816
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 the customer called about cath 57165816 had a blockage and needs a replacement lot# ngku4025.Processed pu/ex.Then customer stated she needs the drain bag replaced as well asked was it an issue with the drain bag and she stated no you can't use the same drain bag with the same cath.Placed on hold and confirmed with sup and she stated we don't change the drain bag when it's an issue with the foley cath and while on hold she hung up informed that the drain bags is not changed out if she has an issue with the cath and she stated well if you're not going to send another drain bag that is fine i'm not using the same bag with the same cath and the call was branded.
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: indications for use: all-silicone 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.Warnings: on catheter, do not use ointments or lubricants having a petroleum base.They will damage catheter and may cause balloon to burst.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.Precautions: do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Instructions 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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h.All available udi information is being provided.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 the customer called about cath 57165816 had a blockage and needs a replacement lot# ngku4025.Processed pu/ex.Then customer stated she needs the drain bag replaced as well asked was it an issue with the drain bag and she stated no you can't use the same drain bag with the same cath.Placed on hold and confirmed with sup and she stated we don't change the drain bag when it's an issue with the foley cath and while on hold she hung up informed that the drain bags is not changed out if she has an issue with the cath and she stated well if you're not going to send another drain bag that is fine i'm not using the same bag with the same cath and the call was branded.

• 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 30014 ; 7707846100
• MDR Report Key: 24378842
• Report Number: 1018233-2026-00916
• Device Sequence Number: 16016881
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752(11)250827(17)300430(10)NGKU4025
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 165816
• Device Lot Number: NGKU4025
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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