DUALOK LOCALIZATION WIRE BIOPSY INSTRUMENT
Received Feb 22, 2016 · Event occurred Jan 28, 2016
Report 2020394-2016-00214 · MDR key 5451428
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
LW0107
Lot number
REZF2658
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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 DURING PREPARATION FOR THE PROCEDURE, THE HEALTH CARE PROVIDER ALLEGEDLY NOTICED FOREIGN MATERIAL DESCRIBED AS ADHESIVE ON THE NEEDLE TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INVOLVEMENT.