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

Catalog Number	0167L18
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the foley catheter was inserted, the cuff failed to inflate.The drainage lumen was also clogged and burst upon pumping.
Additional Manufacturer Narrative
Initial reporter 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.
Additional Manufacturer Narrative
The reported event was confirmed-manufacturing related.The product had caused the reported failure.Sample has been evaluated and observed that the irrigation eye was not properly punched that might be the cause that water flow out slow from the irrigation eye.Introduced water into the inflation lumen and the balloon of catheter can be inflated and deflated without difficulties.Evaluation found that the water flow out slow from the irrigation eye.Microscopic examination observed that the irrigation eye was not properly punched.Hence, this complaint is confirmed manufacturing related.A potential root cause could be eye punch (eye slug not removed) caused no flow/reduce flow at time placement.The labeling and instructions for use were found to be adequate.A review of the manufacturing process indicates that the process is capable of producing of this type of defect.However, current in-process controls are adequate to identify the defect or verify the product integrity.Initial reporter facility name: (b)(6) hospital organization 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 after the foley catheter was inserted, the cuff failed to inflate.The drainage lumen was also clogged and burst upon pumping.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).The reported event was confirmed ¿ manufacturing related.The product had caused the reported failure.Sample has been evaluated and observed that the irrigation eye was not properly punched that might be the cause that water flow out slow from the irrigation eye.No abnormality observed on the drainage lumen.Introduced water into the inflation lumen and the balloon of catheter can be inflated and deflated without difficulties.Introduced water through the drainage funnel and water able to come out from the drainage eye without difficulty.Evaluation found that the water flow out slow from the irrigation eye.Microscopic examination observed that the irrigation eye was not properly punched.Hence, this complaint is confirmed manufacturing related.A potential root cause could be eye punch (eye slug not removed) caused no flow/reduce flow at time placement.The labeling and instructions for use were found to be adequate.A review of the manufacturing process indicates that the process is capable of producing of this type of defect.However, current in-process controls per pfmea are adequate to identify the defect or verify the product integrity.Correction: e.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 after the foley catheter was inserted, the cuff failed to inflate.The drainage lumen was also clogged and burst upon pumping.

• 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: 23095850
• Report Number: 1018233-2025-08338
• Device Sequence Number: 21138541
• Product Code: KOD
• UDI-Device Identifier: 00801741018954
• UDI-Public: (01)00801741018954(11)250111(17)290928(10)MYJX3457
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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,Followup
• Report Date (Section B): 12/05/2025

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: 0167L18
• Device Lot Number: MYJX3457
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 12/05/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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