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

Catalog Number	0165L20
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter fax number provided (b)(6).Initial reporter phone number provided (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.
Event or Problem Description
It was reported that the foley catheter had obstruction due to urine blockage in the foley catheter within one week after insertion.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The initial reporter's fax number: (b)(6).The reported event was confirmed cause unknown.The product had caused the reported failure.Sample evaluated and observed there was no visible kink or dent was observed on both catheter shaft.Water was introduced into inflation lumen and no blockage or obstruction was observed.Balloons of both catheters can be inflated and deflated without difficulties.Flow rate test was performed and found to be failed.Dissected the catheter and found there was white sediment at the drainage eye and lumen area that causing drainage lumen clogged which can lead to the flowrate issue.However, the exact cause of how and when problem occurred could not determine.However, there was capa 13129782 was issued to document the investigation.A potential root cause for this failure could be user related (example: over aspirated, incorrect syringe) or collapse lumen or sac close eye or valve damage or salt accumulation.A review of the device labelling has been conducted for investigation purposed.A review of the device history record did show the affected date code 5fy042 show 0 percent rejection in process scrap related to clogged.Lot file review was performed on the lot and does not indicate any reject or rework associated with this issue.Therefore, no additional action is required at this time.Corrections: d, e, f, h.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 the foley catheter had obstruction due to urine blockage in the foley catheter within one week after insertion.Per notification from investigator on 10apr2026, it was reported that additional samples were (lot mykq1663x1, lot mykp6655x2, lot mykn1614x2 failed flowrate test and observed white sediment in lumen was found during sample evaluation on 09feb2026.

• Brand Name: BARDEX® LUBRICATH® 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: 23764805
• Report Number: 1018233-2025-10904
• Device Sequence Number: 9667366
• Product Code: EZC
• UDI-Device Identifier: 00801741017506
• UDI-Public: (01)00801741017506(11)250721(17)270728(10)MYKQ6508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• 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): 04/16/2026

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: 0165L20
• Device Lot Number: MYKQ6508
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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