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

Catalog Number	0167V18S
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2026
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.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.
Event or Problem Description
It was reported that, on the second day after a single-use sterile urinary foley catheter was inserted for the patient, at 10:50 a.M.While resting in bed, the patient reported fluid leaking from the urethral opening.The patient immediately notified the nursing staff.Upon examination, the foley catheter was found to have slipped out.The catheter balloon was intact with no rupture, and the saline solution had been completely drained.The patient had no urethral injury.The incident was reported to the physician, who confirmed that 20 ml of saline had been injected into the balloon during catheter insertion, confirming that the procedure was performed according to standard protocol.The patient was reassured and provided with health education, advised drinking plenty of fluids, and encouraged to attempt spontaneous urination.Urination status was monitored.

• 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 ; +1(770)784-6100
• MDR Report Key: 24744007
• Report Number: 1018233-2026-02109
• Device Sequence Number: 9166019
• Product Code: KOD
• UDI-Device Identifier: 00801741019210
• UDI-Public: (01)00801741019210(11)241012(17)290628(10)MYJW1576
• 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): 08/06/2026

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: 0167V18S
• Device Lot Number: MYJW1576
• Was Device Available for Evaluation?: No
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2024
• 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