DAVOL® FEMALE CATH KIT
Received Jul 25, 2017
Report 1018233-2017-03943 · MDR key 6742806
Device
Generic name
Female Catheter Kit
Manufacturer
Productos Para El Cuidado De La Salud -9611590Catalog number
0035380
Lot number
NGAW1065
Product problems
- Hole In Material
- Material Integrity Problem
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 THE GLOVES IN THE FEMALE CATHETER KIT HAD HOLES IN THEM.
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 GLOVES IN THE FEMALE CATHETER KIT HAD HOLES IN THEM.