LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE
Received Aug 11, 2017
Report 1018233-2017-04202 · MDR key 6789876
Device
Generic name
Leg Bag
Manufacturer
Productos Para El Cuidado De La Salud -9611590Catalog number
150719
Lot number
UNK
Product problems
- Disconnection
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. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE LEG BAG HAD BEEN DISCONNECTING FROM CATHETER.
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 LEG BAG HAD BEEN DISCONNECTING FROM CATHETER.