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

Catalog Number	1758SI18
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a few days after placement urine leakage from the side of the foley catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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
The reported event is inconclusive due to the material number for sample return is different from the material number reported.Visual: received two (2) used all-silicone foley catheter without original packaging.Verified material number: 2758j18 and manufacturing lot number: ngjx3748.Upon visual inspection it was noted that material number for sample returned (2758j18) is different from the material number reported (2758j12).Catheter 1 (batch: ngjx3748 and material number: 2758j18): urine lumen filled with water and flow was normal.No blockage present.No leaks present.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.Catheter 2 (batch: ngjx3748, material number: 2758j18): urine lumen filled with water and flow was normal.No blockage present.No leaks present.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the investigation results, and no additional action is required at this time.Correction: d, f, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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 a few days after placement urine leakage from the side of the foley catheter.
Event or Problem Description
It was reported that, few days after placement urine leakage from the side of the foley catheter.
Additional Manufacturer Narrative
The reported event is inconclusive due to the material number for sample return is different from the material number reported.Photo: received 11 photo samples.Ten (10) photo samples showcase an overview of an all-silicone foley catheter.Eleventh photo sample showcase a piece of paper with native writing.Visual: received two (2) used all-silicone foley catheter without original packaging.Verified material number 2758j18 and manufacturing lot number ngjx3748.Upon visual inspection it was noted that material number for sample returned (2758j18) is different from the material number reported (2758j12).Catheter 1 (batch ngjx3748 and material number 2758j18): this sample will be tested for "leaks." urine lumen filled with water and flow was normal.No blockage present.No leaks present.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.Catheter 2 (batch ngjx3748 material number 2758j18): this sample will be tested for "leaks." urine lumen filled with water and flow was normal.No blockage present.No leaks present.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.This report references a us equivalent device.The us udi equivalent for this product number is used.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® LUBRI-SIL® I.C. 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: 23005910
• Report Number: 1018233-2025-07681
• Device Sequence Number: 13401660
• Product Code: EZL
• UDI-Device Identifier: 00801741025235
• UDI-Public: (01)00801741025235(11)241103(17)291102(10)NGJX3748
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• 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,Followup
• Report Date (Section B): 04/01/2026

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: 1758SI18
• Device Lot Number: NGJX3748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 03/25/2026; 04/01/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 03/26/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2024
• 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