MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® All-Silicone Foley Catheter

Catalog Number	165816
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hematuria (2558); Insufficient Information (4580)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use there were complaints from various parts of the or about this bardex all-silicone 2-way urinary foley catheter.They were also seeing an increased number of patients with hematuria, and it was asked if there had any recent changes to the catheter.Nothing was found about that in the file only documented at the end of 2024 did not saw any supplied alternatives.This concerns lot mykz2589 and still had stock.They are willing to contact bd regarding the issue or perhaps if a sales representative or product specialist could assist with this issue.Per follow up information received via rcc on 10jul2026, stated that received so many complaints about hematuria following insertion that this is not an isolated case.The colleagues are particularly surprised by the shape of the catheter, the multiple ridges and are wondering if they¿re doing something wrong.Perhaps it would be better if you gave me a quick call or popped in sometime? per follow up information received on 07/16/26, stated that visited the client today and spoke with various departments in the or: surgery, cardiology, and urology.They all have the same problem: a damaged urethra after inserting an all silicone catheter.This happens right at insertion.They have been using the all silicone catheters in the or since 2024.Previously, they used our latex catheter, 1245**.The client believes the problems are caused by the ribbed edge of the balloon.Need to investigate that.For now, advised switching back to our latex catheters to circumvent the problem for the time being.As long as the patient does not have a latex allergy, they will return to latex catheters for now.If the hospital does not want to do this, they will look for a silicone catheter with an integrated balloon to avoid the ribs around the balloon.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).Initial reporter fax number: (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: 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® All-Silicone Foley Catheter
• Common Device Name: Silicone 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 ; +1(770)784-6100
• MDR Report Key: 25867748
• Report Number: 1018233-2026-04780
• Device Sequence Number: 21491691
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752(11)250426(17)300331(10)NGKR0142
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: NGKR0142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/19/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2025
• 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