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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use sterile water leak in the foley catheter.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Evaluation determined that the product did not meet specifications.Visual: received 1 drainage bag with an inlet tube, sample port connector, catheter, 2 syringes, tes and packaging label.Verified material number 2758j14 and catheter lot number nglp3103.Functional: catheter filled with 10ml mbs using returned slip tip syringe.Upon inflation lumen to lumen leakage present.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Correction: d,h.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: 50206246
• Report Number: 1018233-2026-05289
• Device Sequence Number: 20201072
• Product Code: MJC
• UDI-Device Identifier: 00801741025211
• UDI-Public: (01)00801741025211(17)280828(10)MYLR9450
• 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): 09/21/2026

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: 1758SI14
• Device Lot Number: NGLP3103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2026
• 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