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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
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.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 during use the health professional was able to fill the foley catheter cuff with water but could not drain it.It was also mentioned that checked on the inside of the tank, and both filling and draining worked.
Event or Problem Description
It was reported that during use the health professional was able to fill the foley catheter cuff with water but could not drain it.It was also mentioned that a check on the inside of the tank determined that both filling and draining worked.
Additional Manufacturer Narrative
Evaluation determined the product met specifications, and no product nonconformance were identified.A visual evaluation of the returned sample noted one opened (without original packaging), used silicone temp sensing foley catheter.A visual inspection determined that the catheter had no physical defects w present.The balloon was inflated with 10 ml of methylene blue solution (3 drops 1 percent aqueous methylene blue per 100 milliliters distilled water) with returned syringe and it inflated properly; it was observed that the balloon symmetry was approximately 70 to 30 ratio.The in house syringe was connected and the balloon deflated passively in 1 minutes 08 seconds.The reported event was unable to be reproduced.The labeling was found to be adequate.A dhr review was not necessary since based on the information received and the results of the investigation, there is no indication that the event is manufacturing related.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d,e.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: 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 ; +1(770)784-6100
• MDR Report Key: 25648333
• Report Number: 1018233-2026-04238
• Device Sequence Number: 17608475
• Product Code: MJC
• UDI-Device Identifier: 00801741025204
• UDI-Public: (01)00801741025204(11)250106(17)291219(10)NGJX3745
• Combination Product (Y/N): Y
• Initial Reporter State: NA
• 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): 09/09/2026

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: NGJX3745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/28/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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: Unknown