BD FACS SAMPLE PREP ASSISTANT III
Received Jul 15, 2021 · Event occurred Jun 5, 2021
Report 2916837-2021-00308 · MDR key 12175023
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 Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE TOWER OVERFLOW.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00308 WAS SENT IN ERROR. THE LEAKAGE WAS "CONTAINED" "WITHIN" THE INSTRUMENT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE TOWER OVERFLOW.