GHIATAS LOCALIZATION WIRE
Received Apr 21, 2021
Report 2020394-2021-80364 · MDR key 11701088
Device
Generic name
Breast Localization Wire
Manufacturer
Bard Peripheral Vascular, Inc.Model number
47920Catalog number
47920
Lot number
REDY1962
Product problems
- Failure to Advance
- Device Contamination with Chemical or Other Material
- Failure to Advance
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER FOR THE REPORTED MALFUNCTION WAS PROVIDED, THEREFORE, A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION AND ONE ELECTRONIC PHOTO WAS PROVIDED AND REVIEWED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO ADVANCE AND FOREIGN MATERIAL ISSUE. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.
Description of Event or Problem
A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 47920 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.