BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
Received Feb 7, 2025 · Event occurred Jan 10, 2025
Report 3027394506-2025-00001 · MDR key 21333368
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338962
Lot number
NA
Product problems
- Contamination of Device Ingredient or Reagent
- Contamination of Device Ingredient or Reagent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART BLEACH MIXED WITH PATIENT SAMPLES WHICH IMPACTED PATIENT RESULTS. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT BLEACH IS GETTING INTO SAMPLES.
Additional Manufacturer Narrative
H.3. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF UNEXPECTED RESULTS WAS NOT CONFIRMED. THE POTENTIAL CAUSE COULD NOT BE DETERMINED. THE FSE INVESTIGATED THE ISSUE, BUT COULD NOT REPRODUCE THE ERROR OR CONFIRM ANY BLEACH CARRYOVER ISSUE. THE INSTRUMENT WAS RETURNED TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.
Additional Manufacturer Narrative
H.3. 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 THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART BLEACH MIXED WITH PATIENT SAMPLES WHICH IMPACTED PATIENT RESULTS. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT BLEACH IS GETTING IN TO SAMPLES.