Bardex® Foley Catheter Silicone Coated
Received Jul 31, 2026 · Event occurred Jul 16, 2026
Report 1018233-2026-05077 · MDR key 50105793
Device
Generic name
Latex Silicone Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
0167V22S
Lot number
MYJR3354
Product problems
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the patient had a Foley catheter after surgery on (b)(6) 2026. During a night round on (b)(6) 2026, the nurse found that the catheter had come out indicating that the balloon had ruptured.
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.