BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jul 20, 2026 · Event occurred Jul 14, 2026
Report 1018233-2026-04833 · MDR key 25884170
Device
Generic name
Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119314
Lot number
UNK
Product problems
- Difficult to Remove
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS PLACED IN THE PATIENT AND AN ATTEMPT WAS MADE TO REMOVE IT, THE WATER WOULDN¿T DRAIN, AND UPON PULLING OUT THE CATHETER, IT TURNED OUT THAT THERE WAS NO STERILE WATER IN THE BALLOON. AFTER THAT, THEY TRIED INJECTING WATER INTO THE BALLOON AND LEAVING IT FOR A DAY, BUT THE WATER STILL DIDN¿T DRAIN. THEY SAID THEY NEED THE REPORT URGENTLY, SO PLEASE CHECK IT. IT MIGHT BE LUMEN TO LUMEN.
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: SECTIONS 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.