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

Catalog Number	0165SI16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Urinary Tract Infection (2120); Peritonitis (2252)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Ibaraki prefecture federation of agricultural cooperatives for health and welfare: (b)(6) medical center.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.
Event or Problem Description
It was reported that a catheter was placed on august 8 for a patient hospitalized in the neurology department due to a cerebral infarction.It was temporarily removed on august 12, but the patient developed urinary retention on august 16, and approximately 700 ml of urine was ejected via catheterization.On august 17, a foley catheter was placed, but the patient complained of abdominal pain.A contrast enhanced ct scan revealed that the catheter had penetrated the bladder wall by approximately 5 cm and was protruding outside the bladder.The patient has developed sepsis due to a urinary tract infection (uti), which has led to peritonitis.

• Brand Name: Bardex® I.C. Foley Catheter
• Common Device Name: Latex 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: 50420798
• Report Number: 1018233-2026-05549
• Device Sequence Number: 13410002
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040658
• 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): 09/17/2026

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: 0165SI16
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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