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

Catalog Number	0165SI14
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the catheter exchange, health professional confirmed that approximately 8 ml of retained fluid had been drained and attempted to remove the foley catheter; however, it did not fall out.A computed tomography (ct) scan revealed that the balloon section contained no retained fluid but appeared to be filled with air.Therefore, following the troubleshooting protocol, health professional removed the catheter using the non-rupture method.It was also mentioned that health professional was present for the tube removal.There is residual air in the balloon section of the device.Based on the ct images taken prior to tube removal, it appears there was slightly more residual air at that time.Need to verify this.Since this patient was transferred from another hospital, the product code is believed to be 7760014lr.
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® I.C. 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: 50841690
• Report Number: 1018233-2026-06039
• Device Sequence Number: 16027592
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• Combination Product (Y/N): Y
• Initial Reporter State: NA
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• 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: 0165SI14
• 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: 09/17/2026
• 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