BARDEX® ALL-SILICONE FOLEY CATHETER
Received Jul 12, 2026 · Event occurred Jul 2, 2026
Report 1018233-2026-04534 · MDR key 25791276
Device
Generic name
Silicone Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
165814
Lot number
UNK
Product problems
- Material Invagination
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 BALLOON HAD COMPLETELY DEFLATED AND A FOLD AT THE BALLOON LEVEL WAS VISIBLE AFTER REMOVAL ,2 OTHER CATHETERS WERE TESTED, AND THE BALLOON FOLDED EACH TIME, THIS ISSUE HAD BEEN RAISED IN 2025 BY ANOTHER SECTOR FOR THIS SAME PRODUCT. THE COMPLAINT WAS CANCELED AND NOT FORWARDED TO YOU BECAUSE THE STAFF HAD INFLATED THE BALLOON WITH 7ML INSTEAD OF THE INDICATED 5ML.