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

Catalog Number	165808
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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.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 when the foley was inserted the catheter was defective and punctured.
Event or Problem Description
It was reported that when the foley was inserted the catheter was defective and punctured.
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: warnings: ¿ on catheter, do not use ointments or lubricants having a petroleum base.They will damage catheter and may cause balloon to burst.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.¿ 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.Precautions: ¿ do not use device if package is opened or damaged.¿ do not aspirate urine through drainage funnel wall.¿ should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.¿ 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.The dhr review could not be performed without a lot number.No additional actions can be taken at this time.Corrections: d, 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.

• Brand Name: BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE 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: 23951633
• Report Number: 1018233-2025-11578
• Device Sequence Number: 16141972
• Product Code: KOD
• UDI-Device Identifier: 00801741029714
• UDI-Public: (01)00801741029714
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• 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): 02/12/2026

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: 165808
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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