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

Catalog Number	0102L16
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter was leaking when it was being used.They don't have the item.No replacement is needed at this time.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states: precautions: - do not use device if package is opened or damaged.- do not aspirate urine through the drainage funnel wall.- should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Instructions for use: - visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use insertion: 1.Wash hands.2.Use aseptic technique to prepare the patient for catheter insertion.3.Use aseptic technique to remove the catheter from package.Connect catheter to urine collection container as needed.4.Lubricate the catheter.If hospital policy permits, it is possible to inject lubricant into the urethra.5.Catheterize the patient using dominant hand.A.If coude tip, insert with the curve facing upwards.6.When catheter tip has entered bladder, urine will flow through the catheter.A.For female anatomy, insert catheter 2 more inches (approximately 5 cm).B.For male anatomy, insert catheter all the way to bifurcation.7.Inflate the balloon with pre filled water syringe if included.A.If pre filled syringe is not included, then use a slip tip or luer lock syringe to fill catheter balloon with sterile water.Do not use needle.B.Do not exceed recommended capacities as stated on the applicable labeling of the catheter.C.The chart below provides additional information on inflation volume and balloon size.D.Inflation volume (a) incorporates the volume required to pass through lumen and fully inflate the specific balloon size (b).8.Gently pull the catheter until the catheter balloon is snug against the bladder neck.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: f, h.Udi format updated with available product information per gudid.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 they received a call from the patient's daughter and stated the foley catheter item 0102l16, sent in november was leaking when it was being used, potentially due to a product quality, and needed to be changed early.They indicated the item included on po 2377178 sent in december did not have the same product quality issue.They did not have the packaging for either catheter for a lot number.Also asked, are they able to get a replacement quantity 1 of the item sent out.They don't have the item.No replacement is needed at this time.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• 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: 24165207
• Report Number: 1018233-2026-00232
• Device Sequence Number: 9129808
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 0102L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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