BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jun 26, 2026 · Event occurred Jun 18, 2026
Report 1018233-2026-04156 · MDR key 25641977
Device
Generic name
Temperature-sensing Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119316
Lot number
UNK
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER FACED LEAKAGE OF STERILE WATER NEAR THE JUNCTION OF THE SHAFT AND THE FUNNEL.