BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Received Jul 1, 2026 · Event occurred Jun 25, 2026
Report 1018233-2026-04273 · MDR key 25681902
Device
Generic name
Temperature-sensing Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
119314
Lot number
MYKY4802
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 THE FOLEY CATHETER WAS DURING USE IN AN ECTOPIC PREGNANCY SURGERY. THE TIP OF THE BALLOON WAS TORN, CAUSING STERILE WATER TO LEAK. THERE WAS DAMAGE TO THE BALLOON PART AND STERILE WATER LEAKING FROM THERE.