BARDEX® I.C. FOLEY CATHETER
Received Jul 25, 2017 · Event occurred Jun 30, 2017
Report 1018233-2017-03940 · MDR key 6742807
Device
Generic name
Foley Catheter (latex)
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
0165SI14
Lot number
MYBPBB11
Product problems
- Improper Flow or Infusion
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 WATER FLOWED INTO THE URINE DRAINAGE BAG WHEN THE USER INJECTED WATER INTO THE CATHETER FOR PRETEST. THE CATHETER WAS REPLACED.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR ON A 3500A FORM. THE REPORTED EVENT WAS FOUND TO BE EXEMPT FROM REPORTING, PER EXEMPTION E1997009.
Description of Event or Problem
IT WAS REPORTED THAT WATER FLOWED INTO THE URINE DRAINAGE BAG WHEN THE USER INJECTED WATER INTO THE CATHETER FOR PRETEST. THE CATHETER WAS REPLACED.