BD FACS SAMPLE PREP ASSISTANT III
Received Dec 24, 2020 · Event occurred Nov 27, 2020
Report 2916837-2020-00325 · MDR key 11070604
Device
Generic name
Automated Pipetting, Diluting And Specimen Processing Workstations
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesModel number
647205Catalog number
647205
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SHOWED THAT THIS COMPLAINT IS NOT REPORTABLE. THE MDR FOR THIS COMPLAINT SHOULD BE CONSIDERED CANCELLED.
Description of Event or Problem
IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III HAD FOREIGN MATTER IN THE SAMPLE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD FACS¿ SAMPLE PREP ASSISTANT III. EDIONE REIS: (B)(6) 2020, 19:42:43 (GMT) THE EQUIPMENT IS CONTAMINATING THE ANTIBODIES WITH BLOOD DURING PIPETTING."
Additional Manufacturer Narrative
INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III HAD FOREIGN MATTER IN THE SAMPLE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD FACS¿ SAMPLE PREP ASSISTANT III. (B)(6). THE EQUIPMENT IS CONTAMINATING THE ANTIBODIES WITH BLOOD DURING PIPETTING."