BARDEX® I.C. FOLEY CATHETER
Received Jul 1, 2026 · Event occurred Jun 23, 2026
Report 1018233-2026-04265 · MDR key 25680985
Device
Generic name
Foley Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
0165SI14
Lot number
MYLQ4690
Product problems
- Material Rupture
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 FOLEY CATHETER HAD NO PROBLEM DURING THE PRETEST, BUT THE BALLOON RUPTURED RIGHT AFTER IT WAS PLACED IN THE PATIENT.