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

Catalog Number	0166L18
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse attempted to deflate a catheter balloon with 30 ccs instilled, but no water returned with neutral syringe pressure.Using vacuum pressure, only 4 mls were removed.Assistance from another nurse was requested, and they decided to cut the balloon line, resulting in small drips.Using a blue tapered end with a 10-cc syringe, they obtained another 4 mls, totaling approximately 9 mls.The catheter was slightly advanced before the balloon deflated.After no more drainage was noted, slight pressure was applied, and the catheter was removed smoothly and painlessly.The balloon area was slightly puffy with no visible creases, and the end was intact.The catheter was saved for reporting.
Additional Manufacturer Narrative
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 nurse attempted to deflate a catheter balloon with 30 ccs instilled, but no water returned with neutral syringe pressure.Using vacuum pressure, only 4 mls were removed.Assistance from another nurse was requested, and they decided to cut the balloon line, resulting in small drips.Using a blue tapered end with a 10-cc syringe, they obtained another 4 mls, totaling approximately 9 mls.The catheter was slightly advanced before the balloon deflated.After no more drainage was noted, slight pressure was applied, and the catheter was removed smoothly and painlessly.The balloon area was slightly puffy with no visible creases, and the end was intact.The catheter was saved for reporting.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample condition.It was unknown whether the product had caused the reported failure.Sample was evaluated and observed inflation eye are meet internal specification.However, due to poor sample condition the complete investigation could not be performed and this complaint is classified as inconclusive-poor sample condition.The potential root cause for this failure mode could be thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft¿ and might be contributed by user related, example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Correction: d, h.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® 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: 22320992
• Report Number: 1018233-2025-04944
• Device Sequence Number: 15658328
• Product Code: KOD
• UDI-Device Identifier: 00801741017599
• UDI-Public: (01)00801741017599(11)240928(17)290528(10)MYJV1287
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 0166L18
• Device Lot Number: MYJV1287
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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