BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
Received Dec 23, 2024 · Event occurred Nov 28, 2024
Report 2916837-2024-00055 · MDR key 21009508
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
663029
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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 WHILE USING BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD CARRY OVER INVOLVING PATIENT SAMPLES OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN FACT, THE PINCH VALVE ISSUE CAN CAUSE THE SIT FLUSH TO NOT BE PERFORMED SUFFICIENTLY, WHICH CAN THEN LEAD TO SAMPLE CARRYOVER. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2.:CARRYOVER BETWEEN PATIENT SAMPLES.
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.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE ISSUE WITH CARRYOVER WAS CONFIRMED. THE CAUSE OF THE COMPLAINT WAS DETERMINED TO BE A BAD PINCH VALVE. THE CUSTOMER HAD INITIALLY REPORTED CARRYOVER OBSERVED ON THIS INSTRUMENT AND A BD APPLICATION SPECIALIST CONTACTED THEM TO DISCUSS THE ISSUE. THE APPLICATION SPECIALIST RECOMMENDED A REPLACEMENT OF THE PINCH VALVE, AND FOLLOWING THE REPLACEMENT OF THE PINCH VALVE WITH AN ISOLATION VALVE IN A FUTURE WORK ORDER, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED PER BD SPECIFICATIONS. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD CARRY OVER INVOLVING PATIENT SAMPLES OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN FACT, THE PINCH VALVE ISSUE CAN CAUSE THE SIT FLUSH TO NOT BE PERFORMED SUFFICIENTLY, WHICH CAN THEN LEAD TO SAMPLE CARRYOVER. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES.