BBL
Received Jan 27, 2026 · Event occurred Jan 7, 2026
Report 1119779-2026-00026 · MDR key 24192586
Device
Generic name
Stains, Microbiologic
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
212542
Lot number
5169590
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 WHILE USING ONE (1) BD BBL¿ GRAM IODINE (STABILIZED), THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM IODINE (STABILIZED), THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY - THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE GRAM IODINE STABILIZED 250ML, CATALOG NUMBER 212542, BATCH NUMBER 5169590, COMPLAINT # (B)(4) FOR UNSATISFACTORY PERFORMANCE. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A BATCH HISTORY REVIEW OF GRAM CRYSTAL VIOLET. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE DEFECT IN QUESTION FOR THIS PRODUCT. ONE PHOTO WAS RECEIVED. THE PHOTO DEPICTS A MICROSCOPIC VIEW OF GRAM-NEGATIVE CULTURE AND TWO DARK PURPLE NONBACTERIAL ARTIFACTS. RETURN WAS RECEIVED ON 02/26/26 AFTER TESTING WAS COMPLETED. PACKAGE WAS RECEIVED DAMAGED AND SPILLED WITH MIXED MATERIALS. CONTENT INSIDE NOW MIXED MATERIALS AND CAN BE CONTAMINATED. NO FURTHER TESTING CAN BE CONDUCTED THIS TIME A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH. THE SOLUTION APPEARANCE WAS SATISFACTORY AND COMPARABLE TO THE CONTROL; BOTH WERE A DARK BROWN SOLUTION. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF E. COLI ATCC 25922 AND S. AUREUS ATCC 25923 CONTROLS WERE EVALUATED AND HAD SATISFACTORY STAINING RESULTS WITH A RETENTION AND CONTROL BATCHES. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR UNSATISFACTORY PERFORMANCE.