BARDEX® I.C. CARSON MODEL COUDE TIP FOLEY CATHETER
Received Jul 14, 2026 · Event occurred Jul 4, 2026
Report 1018233-2026-04596 · MDR key 25814316
Device
Generic name
Latex Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
0168SI16
Lot number
NGKZ2701
Product problems
- Fluid/Blood Leak
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 URINE LEAKAGE AROUND FOLEY INSERTION SITE. FOLEY INSERTED FOR 5 DAYS.