MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubricath® Pediatric Foley Catheter; Latex Foley Catheter

Catalog Number	0165PL08
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026 the 8fr bard foley catheter was inserted in the operating theatre.On (b)(6) 2026 low urine output was noted.The catheter was flushed by the dr of pediatric intensive care unit.After discussion with the surgical team, the catheter was removed due to persistent poor drainage.On (b)(6) 2026 the second 8fr bard foley catheter was inserted.Low urine output recurred.Flushing yielded approximately 10ml of urine, after which the catheter was removed on (b)(6) 26.On (b)(6) 2026 a third 8fr bard foley catheter was inserted.Urine output was seen only after flushing, indicating ongoing drainage difficulty.Repeated low urine output occurred despite three catheter insertions using the same size 8fr and same brand bard.The urine output improved only after catheter flushing, suggesting a mechanical drainage problem rather than true oliguria.Bedside ultrasound demonstrated a distended bladder despite minimal catheter output, further supporting impaired catheter drainage.It was reported that the patient was a pediatric at the age of 1year 10months and they used 8fr bardia foley catheter.Hcp feels they received the stock the latex quality and the length of the foley catheter size was uneven and sometimes comes with bend.Per follow up information received via rcc on 18feb2026, stated that they have changed three catheters at one patient, unable to get the urine output.No patient injuries.They have changed the catheters to other find better urine output through catheters and have found the bend while taking catheter from the pack and shared the picture an example found in the ip pharmacy.They felt this bend could be reason not getting urine output.
Additional Manufacturer Narrative
Initial reporter phone number:(b)(6).Initial reporter complete facility name: (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® Lubricath® Pediatric Foley Catheter
• Common Device Name: Latex 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: 24445376
• Report Number: 1018233-2026-01191
• Device Sequence Number: 10364613
• Product Code: EZC
• UDI-Device Identifier: 00801741017667
• UDI-Public: (01)00801741017667(11)230116(17)270828(10)MYGY1117
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K910846
• 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): 09/03/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0165PL08
• Device Lot Number: MYGY1117
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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; Other
• Patient Sex: Unknown