MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® FOLEY CATHETER SILICONE COATED

Catalog Number	0167V16S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the patient was admitted to the gastroenterology department on (b)(6) 2025, presenting with nausea and vomiting for 2 days.Due to critical condition, the patient was transferred to the intensive care unit on (b)(6) 2025.Diagnosis 1.Acute biliary pancreatitis 2.Gallbladder stones with acute cholecystitis.Per physician orders, a single-use sterile urinary foley catheter was indwelling on (b)(6) 2025, for urinary drainage.The outer packaging was carefully inspected for integrity prior to use.Half an hour later, the nurse discovered the implanted disposable sterile urinary catheter had slipped out.Upon immediate inspection, the catheter's balloon was found ruptured.After replacing the disposable sterile urinary catheter, the issue did not recur.Examination revealed no urethral injury, and urinary drainage remained normal.
Additional Manufacturer Narrative
Initial reporter name: (b)(6) hospital.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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® FOLEY CATHETER SILICONE COATED
• 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 ; 7707846100
• MDR Report Key: 23879671
• Report Number: 1018233-2025-11425
• Device Sequence Number: 4706862
• Product Code: KOD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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: 0167V16S
• Device Lot Number: MYJP2142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 07/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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