BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jul 1, 2026 · Event occurred Jun 22, 2026
Report 1018233-2026-04257 · MDR key 25680981
Device
Generic name
Temperature-sensing Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119314
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. 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.
Description of Event or Problem
IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE FOLEY CATHETER INTO THE PATIENT AND PERFORM BALLOON DILATION, I NOTICED WATER LEAKING FROM THE CATHETER.