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 Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).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 during the operation, a foley catheter cuff test was performed, and the catheter was inserted in the patient.During surgery, and no urine could be confirmed in the collection bag, so a catheter check was performed, revealing leakage of sterile distilled water from the 2-way portion.Another 119316 catheter was inserted.The first one occurred during surgery, but the second inserted product was defective.While being transferred from the operating room to the intensive care unit, leakage of sterile water from the 2-way portion was noticed.However, since two balloons were already inserted in the same patient and urethral injury was a concern, it was managed as was in the intensive care unit.On the same day, it dislodged, leading to the product being recalled.The patient was male.
Event or Problem Description
It was reported that during the operation, a foley catheter cuff test was performed, and the catheter was inserted in the patient.During surgery, and no urine could be confirmed in the collection bag, so a catheter check was performed, revealing leakage of sterile distilled water from the 2 way portion.Another 119316 catheter was inserted.The first one occurred during surgery, but the second inserted product was defective.While being transferred from the operating room to the intensive care unit, leakage of sterile water from the 2 way portion was noticed.However, since two balloons were already inserted in the same patient and urethral injury was a concern, it was managed as was in the intensive care unit.On the same day, it dislodged, leading to the product being recalled.The patient was male.
Additional Manufacturer Narrative
The initial reporter's facility name: national cerebral and cardiovascular center.The reported event is confirmed manufacturing related.This is addressed by capa 12182448.Visual evaluation noted inflated catheter with 10ml mbs using in house syringe.During inflation, pinhole at trifurcation site found measuring 0.019in.Therefore, the reported event is confirmed 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 root cause for this failure, per capa 12182448, is the silicone injected into the forming cavity is entering pre cured, which causes overheating in the gate area or injection point, as a result, the breaking point between the gate and the molded part is not properly generated, which prevents automatic separation.This requires manual detachment, increasing the risk of perforation at the adapter injection point due to the high temperature in the gate caused by the lack of flow in the jacket.Risk review, labeling review, and dhr review are not required as event has already being investigated per capa 12182448.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.

• 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: 24048931
• Report Number: 1018233-2026-00082
• Device Sequence Number: 18478787
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)250110(17)300109(10)NGKN0097
• 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): 04/13/2026

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: NGKN0097
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male