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	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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.Initial reporter name: (b)(6).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 pretesting the foley catheter had difficulty in draining water.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Received (3) photo samples.Visual evaluation of the photo samples notes one opened (without original packaging), used silicone foley catheter with syringe.Verified material number 119314 and lot number ngjx0480.The second photo shows an enlarged image of the catheter balloon with inflation.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 a 3 way temperature sensing catheter with cut portion of inlet tubing and a straight tipped syringe.Verified material number 119316.Visual inspection noted the catheter balloon was partly inflated.Using the returned syringe 2 ml of solution was passively withdrawn from the balloon.Inflated the catheter balloon with 10 ml of methylene blue solution and the catheter was allowed to rest with no observed leaks.Balloon passively delated in 38 sec.After deflation cuffing noted.This is within specification 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.Therefore, the reported event is unconfirmed.Risk, labelling, and dhr reviews are not required as the reported event is unconfirmed.Based on the results of the investigation, no additional actions are needed.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 during pretesting the foley catheter had difficulty in draining water.Per notification from investigator on 30jan2026, it was reported that cuffing was noted during sample evaluation on (b)(6) 2026.

• 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: 23255051
• Report Number: 1018233-2025-08932
• Device Sequence Number: 10245396
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)241119(17)291112(10)NGJX0480
• 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): 03/05/2026

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: NGJX0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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