BD BBL¿ TAXO¿ A
Received Nov 22, 2024 · Event occurred Oct 24, 2024
Report 2647876-2024-00161 · MDR key 20763423
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
231552
Lot number
4023697
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
INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO NO INHIBITION ZONE WITH BACITRACIN TAXO A CATALOG 231552 BATCH NO.: 4023697 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD BBL¿ TAXO¿ A, DISCS, THERE IS NO ZONE OF INHIBITION WHEN TESTING WITH STREP PYOGENES SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD BBL¿ TAXO¿ A, DISCS, THERE IS NO ZONE OF INHIBITION WHEN TESTING WITH STREP PYOGENES SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
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.