BD LEUCOCOUNT¿
Received Aug 8, 2023 · Event occurred Jul 10, 2023
Report 2916837-2023-00159 · MDR key 17477582
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
341003
Lot number
LC0723
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 THERE WAS FOREIGN MATTER/ CONTAMINATION IN THE REAGENT DURING USE WITH THE BD LEUCOCOUNT¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER EACH THERMO CYCLE USE OF THE COMBO CONTROL, DEBRIS IS INCREASING, WHICH IS STARTING TO IMPACT THE BEAD COUNT. CUSTOMER WOULD LIKE TO INVESTIGATE THE ISSUE. BOX WAS OPENED LAST WEEK AND HAS GONE THROUGH 3 THERMAL CYCLES.
Additional Manufacturer Narrative
G.5. PMA / 510(K)#: BK000035. G.5. PMA / 510(K)#: BK000036. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: ANNEX F CODE WAS CORRECTED TO F26 REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES - SAN JOSE REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR MANUFACTURING LOCATION: BECTON DICKINSON AND COMPANY BD BIOSCIENCES- SAN JOSE MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR H.6: BD ACKNOWLEDGES THE CUSTOMER¿S EXPERIENCE REGARDING THE INDICATED FAILURE MODE OF INCREASING DEBRIS WHICH STARTED TO IMPACT THE BEAD COUNT WITH THE REPORTED CUSTOMER EVENT ON BD LEUCOCOUNT COMBO RBC/PLT CONTROL KIT (341003-LC0723). BASED ON THE INVESTIGATION RESULTS CONDUCTED AND PROVIDED BY THE SUPPLIER ON RETAIN SAMPLE: THE DATA IS IN RANGE. PRODUCT HISTORY REVIEW AS REPORTED BY THE SUPPLIER, THE PRODUCT WAS WITHIN SPECIFICATION LIMITS WHEN RELEASED. THE REPORTED ISSUE WAS NOT CONFIRMED. NO SERIOUS INJURY, DEATH, ERRONEOUS RESULTS, OR TREATMENT CHANGE WERE REPORTED THAT AFFECT A PATIENT SAFETY. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS PRODUCT AND REPORTED FAILURES IN ORDER TO IDENTIFY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER/ CONTAMINATION IN THE REAGENT DURING USE WITH THE BD LEUCOCOUNT¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER EACH THERMO CYCLE USE OF THE COMBO CONTROL, DEBRIS IS INCREASING, WHICH IS STARTING TO IMPACT THE BEAD COUNT. CUSTOMER WOULD LIKE TO INVESTIGATE THE ISSUE. BOX WAS OPENED LAST WEEK AND HAS GONE THROUGH 3 THERMAL CYCLES.