BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
Received Jul 21, 2017 · Event occurred Jun 27, 2017
Report 1018233-2017-03855 · MDR key 6734673
Device
Generic name
Temperature Sensing Catheter
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
129414
Lot number
6LA7112
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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 THE USER FOUND A BLACK MATERIAL ADHERING TO THE CATHETER TIP PRIOR TO USE. THE CATHETER WAS REPLACED.
Description of Event or Problem
IT WAS REPORTED THAT THE USER FOUND A BLACK MATERIAL ADHERING TO THE CATHETER TIP PRIOR TO USE. THE CATHETER WAS REPLACED.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.