BD BBL¿ METHYLENE BLUE LOEFFLER STAIN DROPPER
Received Feb 7, 2024 · Event occurred Jan 11, 2024
Report 1119779-2024-00085 · MDR key 18658461
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
261204
Lot number
B02F240M
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
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHEN USING TWO (2) BOXES OF THE BD BBL¿ METHYLENE BLUE LOEFFLER STAIN DROPPER, THE CUSTOMER OBSERVED DEBRIS RESEMBLING WHITE BLOOD CELLS IN QUALITY CONTROL AND BODY FLUID CELL COUNT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 261204 (DROPPER METHYLENE BLUE LOEFFLER), LOT NUMBER B02F240M, WHERE IT WAS OBSERVED THAT THERE WERE ARTIFACTS IN THE SOLUTION. EVENT DESCRIPTION: " STAINS 261204_B02F240M - DEBRIS.¿. COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DHR DID NOT REVEAL ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: NO PHOTOS WERE AVAILABLE. RETURNS WERE EXPECTED BUT NEVER RECEIVED FROM THE CUSTOMER. INSPECTION OF THE RETAINS SAMPLES DID NOT INDICATE THE NOTED ISSUE. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. NO DEFECT WAS OBSERVED IN THE RETENTION TESTING. A COMPLAINT TREND IS NOT PRESENT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN. BD WILL CONTINUE TO MONITOR FOR TRENDING.
Description of Event or Problem
IT WAS REPORTED WHEN USING TWO (2) BOXES OF THE BD BBL¿ METHYLENE BLUE LOEFFLER STAIN DROPPER, THE CUSTOMER OBSERVED DEBRIS RESEMBLING WHITE BLOOD CELLS IN QUALITY CONTROL AND BODY FLUID CELL COUNT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT.