BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jun 25, 2026 · Event occurred Jun 6, 2026
Report 1018233-2026-04109 · MDR key 25620450
Device
Generic name
Temperature-sensing Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119314
Lot number
MYKY1338
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 DURING PLACEMENT, THE FOLEY CATHETER NATURAL REMOVAL WAS CONFIRMED IN WARD 6B, POSSIBLE DUE TO BALLOON BREAKAGE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 22JUN2026, STATED THAT IT WAS UNKNOWN IF ANY BALLOON RUPTURE OCCURRED.