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

Catalog Number	175818
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a two-nurse insertion of a foley catheter 18fr, the nurse noted the syringe to be filled to only 9 ml vs the 10 ml that the package states.It should be inflated catheter 10 ml with sterile water.
Additional Manufacturer Narrative
Initial reporter name: (b)(6) hospital.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.
Additional Manufacturer Narrative
This supplemental mdr is to capture additional information from a follow up, but it does not impact the investigation findings previously submitted.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: foley catheters can be used in patients of all ages.Up to 10 ch per fr is generally considered pediatric sizing; however, the appropriate size should be determined by the healthcare professional.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.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).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.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 during a two-nurse insertion of a foley catheter 18fr, the nurse noted the syringe to be filled to only 9ml vs the 10 ml that the package states it should be inflated catheter 10 ml with sterile water.Per follow up information received via email on 30mar2026, it was reported that the product is no longer available unfortunately.
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: foley catheters can be used in patients of all ages.Up to 10 ch per fr is generally considered pediatric sizing; however, the appropriate size should be determined by the healthcare professional.Inflate the balloon with pre-filled water syringe if included.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.Do not exceed recommended capacities as stated on the applicable labeling.The chart below provides additional information on inflation volume and balloon size.Inflation volume (a) incorporates the volume required to pass through lumen and fully inflate the specific balloon size (b).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d.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 during a two nurse insertion of a foley catheter 18 fr, the nurse noted the syringe to be filled to only 9 ml vs the 10 ml that the package states it should be inflated catheter 10 ml with sterile water.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE 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: 24464323
• Report Number: 1018233-2026-01325
• Device Sequence Number: 10007383
• Product Code: EZL
• UDI-Device Identifier: 00801741034176
• UDI-Public: (01)00801741034176(11)241213(17)291212(10)NGJX4711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 175818
• Device Lot Number: NGJX4711
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 03/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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