BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
Received Aug 16, 2017 · Event occurred Jul 11, 2017
Report 1018233-2017-04256 · MDR key 6797265
Device
Generic name
Temperature Sensing Catheter (latex)
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
129414
Lot number
MYBRB758
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PER ADDITIONAL INFORMATION FROM INVESTIGATORS, THE REPORTED EVENT WAS FOUND TO BE EXEMPT FROM REPORTING, PER EXEMPTION E1998006.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PRETEST, WATER LEAKAGE OCCURRED FROM THE BALLOON OF THE CATHETER AS THE USER INJECTED THE WATER INTO THE DEVICE.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PRETEST, WATER LEAKAGE OCCURRED FROM THE BALLOON OF THE CATHETER AS THE USER INJECTED THE WATER INTO THE DEVICE.