BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
Received Jul 25, 2017 · Event occurred Jul 6, 2017
Report 1018233-2017-03951 · MDR key 6742829
Device
Generic name
Temperature Sensing Catheter
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
129414
Lot number
UNK
Product problems
- Out-Of-Box Failure
- 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
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE USER FOUND A HAIR ATTACHED TO THE TIP OF THE CATHETER UPON OPENING THE PACKAGE.
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 HAIR ATTACHED TO THE TIP OF THE CATHETER UPON OPENING THE PACKAGE.