BD FACSLYRIC¿
Received May 23, 2024 · Event occurred Apr 25, 2024
Report 2916837-2024-00033 · MDR key 19382696
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
663518
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 CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER JUST RECENTLY DISCUSSING WITH ACCOUNT HERE ARE THE CURRENT CONCLUSIONS: 1) THERE SEEMED TO BE ONE PATIENT AFFECTED, ACCOUNT CALLED YESTERDAY AFTERNOON FOR CARRYOVER ISSUES AT END OF DAY.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER JUST RECENTLY DISCUSSING WITH ACCOUNT HERE ARE THE CURRENT CONCLUSIONS: 1) THERE SEEMED TO BE ONE PATIENT AFFECTED, ACCOUNT CALLED YESTERDAY AFTERNOON FOR CARRYOVER ISSUES AT END OF DAY.
Additional Manufacturer Narrative
H6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE A LOOSE SIT PROBE FITTING AND A DETERIORATED WASTE CHECK VALVE. THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ISSUE AND REPLACED VARIOUS FLUIDICS COMPONENTS INCLUDING THE SIT PROBE AND THE CHECK VALVE, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT 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 COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.
Description of Event or Problem
IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER JUST RECENTLY DISCUSSING WITH ACCOUNT HERE ARE THE CURRENT CONCLUSIONS: 1) THERE SEEMED TO BE ONE PATIENT AFFECTED, ACCOUNT CALLED YESTERDAY AFTERNOON FOR CARRYOVER ISSUES AT END OF DAY.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.