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

Catalog Number	1758SI12
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6).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.
Event or Problem Description
It was reported that before patient use, checked if the balloon inflates properly.After confirming inflation, health professional attempted to deflate it, but the distilled water ran out from the foley catheter.Per internal bd comments received on 01dec2025, lumen-to-lumen had occurred.It appeared that distilled water was flowing into the connecting tube on the urine collection bag side.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 11092653.Visual evaluation noted received 1 all silicone foley catheter in leaflet and pouch.Attached to syringe, tray and drainage bag.Using returned solution attempted to inflate with 10 ml methylene blue solution (3 drops 1percent aq methylene blue per 100ml distilled water) but solution immediately leaked to the drainage funnel indicating lumen to lumen leak.Based on the physical sample received the reported event is confirmed manufacturing related and does not meet specifications 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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 before patient use, checked if the balloon inflates properly.After confirming inflation, health professional attempted to deflate it, but the distilled water ran out from the foley catheter.Per internal bd comments received on 01dec2025, lumen to lumen had occurred.It appeared that distilled water was flowing into the connecting tube on the urine collection bag side.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 23768641
• Report Number: 1018233-2025-10926
• Device Sequence Number: 10631770
• Product Code: MJC
• UDI-Device Identifier: 00801741025204
• UDI-Public: (01)00801741025204(17)270628(10)MYKN6860
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• 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): 03/26/2026

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: 1758SI12
• Device Lot Number: MYKN6860
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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