Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter
Received Jul 28, 2026 · Event occurred Jul 22, 2026
Report 1018233-2026-04978 · MDR key 50059469
Device
Generic name
Temp-sensing Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119316M
Lot number
UNK
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported by customer that there was a leak in the Foley Tubing.
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. This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.