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

Catalog Number	365724
Medical Device Problem Codes	Difficult to Remove (1528); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
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.The reported product number is unknown.The udi number for this product is not available.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 for 15 years, the user had no issues using a green foley catheter from the company.Recently, they received a brown replacement due to supply issues.After one day, the user experienced urine and fluid leakage and informed their medical team.The catheter was difficult and painful to remove, with small bubbles noted at the end.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.A potential root cause for this failure mode could be latex top-up activity into the latex tank conducted while forms dipping and surface bubble form during top-up may attached to catheter during frame dipping in latex which was due to poor precaution of the potential failure.The dhr review could not be performed without a lot number.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.Correction- e.The reported product number is unknown.The udi number for this product is not available.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 for 15 years, the user had no issues using a green foley catheter from the company.Recently, they received a brown replacement due to supply issues.After one day, the user experienced urine and fluid leakage and informed their medical team.The catheter was difficult and painful to remove, with small bubbles noted at the end.Per additional information received via email on 10jul2025, customer stated they are maintaining the catheter currently in a ziplock bag.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.Sample was dissected found there was present of salt at the drainage eye which can caused catheter difficult to remove.However, the exact cause of how and when problem occurred could not determined.The potential root cause for this failure could be contributed by thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and states the following: insert foley catheters only for appropriate indications and leave in place only as long as needed.Proper techniques for urinary catheter insertion: - perform hand hygiene immediately before and after insertion - insert urinary catheters using aseptic technique and sterile equipment - use the smallest foley catheter possible, consistent with good drainage - document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record proper techniques for urinary catheter maintenance: - secure the foley catheter.Use the statlock foley stabilization device if provided - maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions - maintain unobstructed urine flow and keep the catheter and collection tube free from kinking - keep the collection bag below the level of the bladder or hips at all times - empty the collection bag regularly using a separate, clean collection container for each patient.Correction- d, g, f, h.Udi format updated with available product information per gudid.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 for 15 years, the user had no issues using a green foley catheter from the company.Recently, they received a brown replacement due to supply issues.After one day, the user experienced urine and fluid leakage and informed their medical team.The catheter was difficult and painful to remove, with small bubbles noted at the end.Per additional information received via email on 10jul2025, customer stated they are maintaining the catheter currently in a ziplock bag.

• Brand Name: BARD® 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 30014 ; 7707846100
• MDR Report Key: 22328028
• Report Number: 1018233-2025-05011
• Device Sequence Number: 8430250
• Product Code: EZC
• UDI-Device Identifier: 00801741077784
• UDI-Public: (01)00801741077784
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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: 365724
• 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: 06/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 08/26/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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