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

Catalog Number	166816
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
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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 by the resource nurse 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.

• Brand Name: Bardex® 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: 24837671
• Report Number: 1018233-2026-02376
• Device Sequence Number: 21408823
• Product Code: GBM
• UDI-Device Identifier: 00801741029806
• UDI-Public: (01)00801741029806(11)251008(17)300331(10)NGKW1785
• 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,Followup
• Report Date (Section B): 08/12/2026

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: 166816
• Device Lot Number: NGKW1785
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 08/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/29/2026; 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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