BARDEX® ALL-SILICONE FOLEY CATHETER
Received Jul 12, 2026 · Event occurred Jun 24, 2026
Report 1018233-2026-04550 · MDR key 25791387
Device
Generic name
Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
165814
Lot number
UNK
Product problems
- Material Split, Cut or Torn
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PLACEMENT IN THE SURGERY CENTER THE FOLEY CATHETER HAD A CRACK, CAUSING URINE LEAKAGE.
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.