MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Catalog Number	1758SI14
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the catheters were inserted due to urinary retention in two patients.The devices remained in situ for up to four weeks.Removal of the catheters was reported to be extremely painful.No patient injury has been reported.However, in one case the patient required radiological intervention to facilitate catheter removal.\ \ in the first patient, an urgent appointment was required due to reduced catheter flow after approximately 14 days of catheterization.The patient had a history of catheter encrustation and had previously presented with an obstructed rüsch catheter.Based on this history, it was decided to switch to a bard lubri-sil catheter.Two urine cultures were performed approximately one month apart.Both cultures demonstrated mixed gram-positive flora at 10,000 to 100,000 cfu/ml, considered consistent with catheter colonization.The patient had cloudy urine associated with residual urine retention.No urinary tract infection (uti) was identified.The patient had previously used intermittent catheterization.Due to penile pain, a suprapubic catheter was subsequently placed.A silicone rüsch catheter was then used for 10 weeks, which is within the recommended indwelling period of 10 to 12 weeks.At the first catheter change following suprapubic catheter placement, the rüsch catheter was replaced with a bard lubri-sil catheter.The balloon could not be deflated, and it was difficult to aspirate fluid through the catheter lumen.As a result, the patient was referred to the radiology department for assistance with catheter removal.Feedback from the radiology team indicated that puncturing the balloon was challenging due to significant encrustation.Basis of complaint.This complaint concerns two bard lubri-sil catheters associated with the following issues:\ ¿ reduced or obstructed catheter flow.\ ¿ significant catheter encrustation.\ ¿ inability to deflate the retention balloon during catheter removal.\ ¿ severe pain during catheter removal.\ ¿ one case requiring radiological intervention to remove the catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.\ \ initial reporter phone: (b)(6)\ \ 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: 50848295
• Report Number: 1018233-2026-06040
• Device Sequence Number: 18648449
• Product Code: MJC
• UDI-Device Identifier: 00801741025211
• UDI-Public: (01)00801741025211(17)300831(10)NGKY4208
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1758SI14
• Device Lot Number: NGKY4208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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