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

Catalog Number	165816
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at around 14:00 hrs, prior to patient being transferred from bed to wheelchair, patient's incontinent brief was noted to be soiled.Both pca and primary nurse intended to provide perineal care prior to transfer.Upon opening brief, foley catheter came out.Foley catheter tip noted to not be inflated.Balloon area was flat.Patient informed primary nurse that the catheter was inserted the day before.Primary nurse assessed foley catheter but using 10 ml syringe and trying to inflate it.No balloon inflation noted, instead, leakage noted.At the time primary nurse inserted a brand-new catheter of the same product.Balloon was inflated of 10 ml.Resistance noted.Urine output noted.One day later, at around 09:30 hrs, foley catheter was initially insitu until during med pass as patient was complaining of discomfort from foley catheter.Patient felt as if foley was not in place.Primary nurse assessed and tugged on catheter with no resistance noted.Primary nurse removed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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: 25884686
• Report Number: 1018233-2026-04843
• Device Sequence Number: 21279492
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752(11)250731(17)300228(10)NGKT3252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040504
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 165816
• Device Lot Number: NGKT3252
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/13/2026; Not provided; 09/24/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/14/2026; 09/06/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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