BARDEX BARDEX® I.C. FOLEY CATHETER
Received Jun 27, 2026 · Event occurred Jun 22, 2026
Report 1018233-2026-04203 · MDR key 25646133
Device
Generic name
Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
0165SI14
Lot number
UNK
Product problems
- Deflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS NO SMOOTH ENTRY OR RETURN OF FIXED WATER INTO THE BALLOON. THERE WAS NO FALL OUT OF THE FIXED WATER.
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.