DAVOL® FEMALE CATH KIT
Received Jul 26, 2017
Report 1018233-2017-03998 · MDR key 6745614
Device
Generic name
Female Cath Kit
Manufacturer
Productos Para El Cuidado De La Salud -9611590Catalog number
0035380
Lot number
NGAW1065
Product problems
- Hole In Material
Patient
Not reported
- No Information
- No Information
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 FEMALE CATHETER KIT CONTAINED DAMAGED GLOVES. THE GLOVES 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. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE FEMALE CATHETER KIT CONTAINED DAMAGED GLOVES. THE GLOVES HAD HOLES IN THEM.