BD BBL¿ GRAM STAIN KIT
Received Apr 2, 2026 · Event occurred Mar 4, 2026
Report 1119779-2026-00601 · MDR key 24766455
Device
Generic name
Stains, Microbiologic
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
212539
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM STAIN KIT, THERE WAS PRECIPITATE PRESENT ON THE SLIDES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. D4. MEDICAL DEVICE LOT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY- THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO KIT GRAM STAIN STABILIZED, CATALOG NUMBER 212539, BATCH NUMBER UNKNOWN, COMPLAINT # (B)(4) FOR SOLUTION APPEARANCE. BACKGROUND: COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. BATCH HISTORY REVIEW: A REVIEW OF THE BATCH HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO TRENDS FOR THIS PRODUCT. RETURNED MATERIAL ANALYSIS: NO RETURNS OR PHOTOS WERE PROVIDED. UNABLE TO TEST RETENTIONS AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATIONAL TESTING/REVIEW: THE CUSTOMER REPORTED THERE WAS A PRECIPITATE IN THE PRODUCT. NO ADDITIONAL TESTING CAN BE PERFORMED AS NO BATCH INFORMATION WAS PROVIDED. CONCLUSION: THIS COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. BD WILL CONTINUE TO TREND SOLUTION APPEARANCE COMPLAINTS AND ASSESS PRODUCT INTENDED USES AGAINST REGULATORY REQUIREMENTS.
Description of Event or Problem
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM STAIN KIT, THERE WAS PRECIPITATE PRESENT ON THE SLIDES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.