BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR
Received Jan 19, 2023 · Event occurred Jan 10, 2023
Report 1119779-2023-00045 · MDR key 16209274
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
231727Catalog number
231727
Lot number
2056543
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 60 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR DURING VALIDATION NO GROWTH OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO GROWTH OF HAEMOPHILUS INFLUENZAE AT THE EDGE OF 60 DISC WITH THE USE OF A COS + FACTOR V MEDIUM DURING VALIDATION NO GROWTH , ARE TESTING NOW WITH OTHER BATCH , TOMORROW NOON 11/1/2023 12H I HAVE TO CALL THE CUSTOMER FOR RESULTS OTHER BATCH.
Additional Manufacturer Narrative
H6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO NO GROWTH FOR TAXO V FACTORS CATALOG 231727 BATCH NO.: 6924935 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
Additional Manufacturer Narrative
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 60 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR DURING VALIDATION NO GROWTH OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO GROWTH OF HAEMOPHILUS INFLUENZAE AT THE EDGE OF 60 DISC WITH THE USE OF A COS + FACTOR V MEDIUM DURING VALIDATION NO GROWTH , ARE TESTING NOW WITH OTHER BATCH , TOMORROW NOON 11/1/23 12H I HAVE TO CALL THE CUSTOMER FOR RESULTS OTHER BATCH.