MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® All-Silicone Foley Catheter

Catalog Number	165814
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the resource nurse with emp, and the staff have been having some trouble with the bardex all silicone foley catheter size 16 with 5cc bulb.They are just falling out of patients according to the patient.Patient required replacement of 4 indwelling catheters and eventually, a latex catheter was placed.No other issue observed with the catheter.Upon testing current stock as well as other sizes and bulb sizes only one side of the catheter is inflating which is leaving the bulb lopsided which can then easily pull out.They have attached a photo of what the catheter looked like.Per additional information received on 07apr2026, it was reported it was 16 and 18 with 5ml bulb and 16 and 18 with 30ml bulb".They called the customer to clarify this information.A 16 and 18fr catheter were inserted into the patient and fell out the same day.The customer inflated a 16, 18 fr with 5cc balloon and 16,18fr 30cc balloon at their desk and the balloons only inflated mostly on one side.They sent the foley inflation/deflation instruction sheet and asked if they followed the instructions when inflating and they said they did.Asked to send a container and prepaid label and they will return all 4 of the catheters they tested.Per follow up information received via email on 06may2026, they have some of the samples.They were not permitted to give names, but they were females and caucasian.Average size and build.Not sure of age.No medical intervention, other than frequent catheter changes on a weekend.Tested samples in office to see what was happening.Tested sizes 12, 14, 16, 18.They have all been the silicone catheters.All those sizes plus can be 5, 10 or 30cc bulb it did not matter, they were all filling on one side only.You will also see in the box that you send me two 30cc catheters that were fully inflated a month ago, now almost deflated and they were not touched.They just sat in their cupboard.Material #165814 - ngkn3064 per notification from investigator on 29jun2026, it was reported that the asymmetric balloon with concentricity 100/0 was found during sample evaluation on (b)(6) 2026.
Additional Manufacturer Narrative
The investigation did not reveal any additional findings as the sample was not available to allow for further evaluation.Visual: received only outside packaging was provided not actual catheter.Our team conducted a review of the reported event, with the available information to ensure the ongoing safety and performance of the product.An investigation has been completed using all information currently available.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.Labeling review: the labeling is found to be adequate.The dhr for catalog (b)(4) with lot number ngkn3064 was reviewed, and no rejects were found by qa.The review did not identify any planned deviations, reworks, component quality issues, or manufacturing discrepancies that could have contributed to the report.Corrections made to tab(s) d and h.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.

• Brand Name: Bardex® 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 ; +1(770)784-6100
• MDR Report Key: 25752802
• Report Number: 1018233-2026-04347
• Device Sequence Number: 10427012
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745(11)250225(17)290930(10)NGKN3064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 165814
• Device Lot Number: NGKN3064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2026
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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