BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
Received Aug 14, 2017 · Event occurred May 9, 2017
Report 1018233-2017-04214 · MDR key 6793310
Device
Generic name
Foley Catheter (latex)
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
129414
Lot number
6GH7042
Product problems
- Inflation Problem
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR ON A 3500A FORM. THE COMPLAINT WILL BE REPORTED VIA A EXEMPTION REPORT PER REMEDIAL ACTION EXEMPTION E1998006.
Description of Event or Problem
IT WAS REPORTED THAT THE USER WAS UNABLE TO INFLATE THE BALLOON.
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 WAS UNABLE TO INFLATE THE BALLOON.