BD FACSDUET¿ SAMPLE PREP
Received Nov 7, 2023 · Event occurred Oct 9, 2023
Report 2916837-2023-00216 · MDR key 18087443
Device
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
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(6) G.1 - REPORTING OFFICE CONTACT - (B)(6) G.1 - MANUFACTURING SITE CONTACT - (B)(6) H.3. BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE REPORTED ISSUE 'ABSOLUTE COUNTING PROBLEM WITH TRUCOUNT TUBES' WAS CONFIRMED. THE POTENTIAL CAUSE WAS CAP PIERCING NEEDLE AND SYRINGE. THE FSE REPLACED THE CAP PIERCING NEEDLE, THE SYRINGE AND VERIFIED VOLUMES DISTRIBUTED WITH WATER AND BLOOD TUBES. THE INSTRUMENT CONFORMS TO SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10
Description of Event or Problem
IT WAS REPORTED THAT BD FACSDUET¿ SAMPLE PREP ABSOLUTE COUNTING PROBLEM WITH TRUCOUNT TUBES IS OCCURRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABSOLUTE COUNTING PROBLEM WITH TRUCOUNT TUBES
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT BD FACSDUET¿ SAMPLE PREP ABSOLUTE COUNTING PROBLEM WITH TRUCOUNT TUBES IS OCCURRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABSOLUTE COUNTING PROBLEM WITH TRUCOUNT TUBES.