BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jul 12, 2026 · Event occurred Jun 25, 2026
Report 1018233-2026-04497 · MDR key 25791120
Device
Generic name
Temperature-sensing Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119314
Lot number
MYLP5267
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, THER WAS LEAK FOUND FROM THE FOLEY CATHETER FUNNEL DURING THE TEST AND THE CUFF FOUND RUPTURED DURING THE PROCEDURE.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.