DUALOK LOCALIZATION WIRE
Received Apr 14, 2020
Report 2020394-2020-02666 · MDR key 9959082
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Model number
LW0057Catalog number
LW0057
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER FOR THE MALFUNCTION IS UNKNOWN, THEREFORE A MANUFACTURING REVIEW COULD NOT BE CONDUCTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL LW0057 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.