LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
Received Jul 28, 2017 · Event occurred Jul 10, 2017
Report 1018233-2017-04024 · MDR key 6752295
Device
Generic name
Foley Catheter Tray (silicone)
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
319214A
Lot number
UNK
Product problems
- Break
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, AS THIS EVENT IS NOT REPORTABLE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A DAMAGE ON THE SAMPLING PORT.
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 THERE WAS A DAMAGE ON THE SAMPLING PORT.