BARDEX® I.C. FOLEY CATHETER
Received Jul 7, 2026 · Event occurred Jun 26, 2026
Report 1018233-2026-04334 · MDR key 25736196
Device
Generic name
Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
0165SI16
Lot number
NGLN3939
Product problems
- Fracture
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 VIA EMAIL THAT DURING ROUTINE CARE AND FLUSHING OF A (SP) FOLEY CATHETER, A MECHANICAL ISSUE WAS IDENTIFIED WITH THE CATHETER FLUSH VALVE. STAFF NOTICED THAT THE FLUSH PORT WAS CRACKING MORE FREQUENTLY DURING FLUSHING. DUE TO THE MALFUNCTIONING VALVE, THE CATHETER COULD NOT BE FLUSHED PROPERLY, WHICH RESULTED IN SEVERAL CATHETERS NEEDING TO BE REPLACED. WE ARE ABLE TO REPOSITION VALVE PLASTIC SOME OF THE TIME FOR PROPER FLUSHING BUT HAVE HAD TO REPLACE THE FOLEY CATHETER SEVERAL TIMES.