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

Catalog Number	119316
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempted to insert a foley catheter in the operating room for urinary catheterization and temperature management during the pre-test, it was reported that sterile water leaked from the cuff and the balloon ruptured.
Additional Manufacturer Narrative
Initial reporter full facility name (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 confirmed manufacturing related.This is addressed by capa 11092653.Received (4) photo samples.Visual evaluation of the photo samples noted a used temp sensing silicone foley catheter.Verified tray material number 29030j16 with lot mykr0244 and material number for catheter 119316 and lot number ngjv3288.The condition of the affected catheter could not be confirmed from the photos provided.Functional testing was not possible based solely on these photos.Received 1 all silicone foley catheter.Verified material number 119316 and manufacturing lot number ngjv3288.Visual inspection noted no obvious observations.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water) using in house syringe.Upon inflation solution leaked from eyelets.When balloon was dissected 0.025 pin gauge fitted within perforation notch.This is out of specification per inspection procedure 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 possible root causes for this failure, per capa 11092653, are "funnel wall thickness to thin due to molding core pin shape" or "extruded tube diameter with variation causing leak in catheter funnel molding." risk review, labeling review, and dhr review are not required as event has already been investigated per capa 11092653.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.
Event or Problem Description
It was reported that when attempted to insert a foley catheter in the operating room for urinary catheterization and temperature management during the pre test.It was reported that sterile water leaked from the cuff and the balloon ruptured.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING 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: 23526434
• Report Number: 1018233-2025-10180
• Device Sequence Number: 10074420
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)240925(17)290923(10)NGJV3288
• Combination Product (Y/N): Y
• 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): 03/18/2026

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: 119316
• Device Lot Number: NGJV3288
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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