BD FACS SAMPLE PREP ASSISTANT III
Received Feb 26, 2021 · Event occurred Feb 2, 2021
Report 2916837-2021-00065 · MDR key 11388967
Device
Generic name
See H.10
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesModel number
647205Catalog number
647205
Lot number
NA
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CUSTOMER HAS NOTICED THAT THE WASHING COLUMN IS OVERFLOWING. THE CUSTOMER HAS CLEANED THE FILTER BUT THE PROBLEM PERSISTS.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00065 WAS SENT IN ERROR. FURTHER INVESTIGATION REVEALED THE LEAK WAS CONTAINED WITHIN INSTRUMENT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Additional Manufacturer Narrative
COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER HAS NOTICED THAT THE WASHING COLUMN IS OVERFLOWING. THE CUSTOMER HAS CLEANED THE FILTER BUT THE PROBLEM PERSISTS.