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

Catalog Number	175820
Medical Device Problem Codes	Unclear Information (4052); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 they discovered that all of our supply of bard lubri-sil all-silicone foley catheters sizes 8fr to 20fr in the stollery or level 1 core have labelling discrepancies.The lot number on outside of package did not match with lot number on product inside package.The balloon fill amounts do not match on the 20fr and 12fr products/packaging.The reference numbers do appear to match with product and packaging.Labeling discrepancies: foley catheter size 8fr.Foley catheter size 10fr.Foley catheter size 12fr.Foley catheter size 14fr.Foley catheter size 16fr.Foley catheter size 18fr.Foley catheter size 20fr.The balloon fill amounts do not match on the 20fr and 12fr products/packaging: foley catheter size 20fr.Foley catheter size 12fr.
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.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states.7.Inflate the balloon with pre-filled water syringe if included.A.If pre-filled syringe is not included, then use a slip tip/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).Inflation volume (a) balloonsize (b) 5 ml, 3 ml.10 ml, 5 ml.Note: drawing may not display actual shape of catheter tip or presence of additional lumen(s).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, 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.
Event or Problem Description
It was reported that they discovered that all of our supply of bard lubri-sil all-silicone foley catheters sizes 8fr to 20fr in the stollery or level 1 core have labelling discrepancies.The lot number on outside of package did not match with lot number on product inside package.The balloon fill amounts do not match on the 20fr and 12fr products/packaging.The reference numbers do appear to match with product and packaging.Labeling discrepancies: foley catheter size 8fr.Foley catheter size 10fr.Foley catheter size 12fr.Foley catheter size 14fr.Foley catheter size 16fr.Foley catheter size 18fr.Foley catheter size 20fr.The balloon fill amounts do not match on the 20fr and 12fr products/packaging: foley catheter size 20fr.Foley catheter size 12fr.

• Brand Name: BARDEX® LUBRI-SIL® 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: 23822596
• Report Number: 1018233-2025-11249
• Device Sequence Number: 18463030
• Product Code: EZL
• UDI-Device Identifier: 00801741034183
• UDI-Public: (01)00801741034183(11)250110(17)280731(10)NGJZ1780
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/30/2026

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: 175820
• Device Lot Number: NGJZ1780
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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