BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Received Jul 12, 2026 · Event occurred Jul 7, 2026
Report 1018233-2026-04540 · MDR key 25791283
Device
Generic name
Silicone Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
1758SI14
Lot number
UNK
Product problems
- Material Puncture/Hole
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT THE FOLEY CATHETER STERILE WATER LEAKAGE OCCURRED AROUND THE FUNNEL. NOTHING COMES INTO CONTACT WITH THE PRODUCT.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED.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.