BD FACS¿ SAMPLE PREP ASSISTANT
Received Nov 30, 2021 · Event occurred Nov 2, 2021
Report 2916837-2021-00471 · MDR key 12897761
Device
Generic name
See H.10
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
650686
Lot number
NA
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT WAS OVERFLOWING BIOHAZARD FROM THE WASH TOWER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THE WASH STATION IS OVERFLOWING. LEAK QUESTIONS FROM SMAX CHECKLIST: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN".
Additional Manufacturer Narrative
AFTER FURTHER REVIEW, THIS COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE. LEAKAGE OF FLUID WAS CONTAINED. LEAKAGE OF FLUIDS ARE UNLIKELY TO LEAD TO A SERIOUS INJURY OR DEATH DUE TO THE PASSIVE NATURE, AND IS NOT LIKELY TO LEAD TO CONTACT OF THE USER OR PATIENT. THEREFORE, THIS COMPLAINT WILL BE CANCELLED.
Description of Event or Problem
IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT WAS OVERFLOWING BIOHAZARD FROM THE WASH TOWER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THE WASH STATION IS OVERFLOWING. LEAK QUESTIONS FROM SMAX CHECKLIST: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN."
Additional Manufacturer Narrative
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.