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

Catalog Number	119110
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 during a cuff check, only small amount of water can be pumped into the foley balloon, but almost no water can be pumped in, causing the water to overflow from the valve.There was a difficulty in water injection.
Event or Problem Description
It was reported that during a cuff check, only small amount of water can be pumped into the foley balloon, but almost no water can be pumped in, causing the water to overflow from the valve.There was a difficulty in water injection.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 12182448.Received 1 all silicone foley catheter.Verified material number 119110 and manufacturing lot number ngkn0350.Visual inspection noted no obvious observations.The catheter balloon was inflated with 3.5ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) using the in-house luer lock syringe and a little solution leaked out from under the inflation cap.After removing the inflation cap and valve and upon further inspection, there was a 0.027" pinhole found under the inflation cap.This is out of specification per inspection procedure ip7603444, revision 0, which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe." the root cause for this failure, per capa 12182448, is the silicone injected into the forming cavity is entering pre-cured, which causes overheating in the gate area or injection point, as a result, the breaking point between the gate and the molded part is not properly generated, which prevents automatic separation.This requires manual detachment, increasing the risk of perforation at the adapter injection point due to the high temperature in the gate caused by the lack of flow in the jacket.Risk review, labeling review, and dhr review are not required as event has already being investigated per capa 12182448.Refer to capa 12182448 for further details.Correction: d,e,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.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC 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: 22904074
• Report Number: 1018233-2025-07123
• Device Sequence Number: 18120479
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001(11)250211(17)291231(10)NGKN0350
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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
• Report Date (Section B): 01/09/2026

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: 119110
• Device Lot Number: NGKN0350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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