BD BBL¿ GRAM CRYSTAL VIOLET
Report
- Report Number
- 1119779-2025-04535
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Date of Event
- August 4, 2025
- Report Date
- December 1, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JTS
- UDI-DI
- 30382902125250
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY- THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE GRAM CRYSTAL VIOLET 250ML, CATALOG NUMBER 212525, BATCH 4344676, AND COMPLAINT # (B)(4) FOR SOLUTION APPEARANCE. 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. FIVE PHOTOS WERE RECEIVED IN A LEU OF RETURN. ONE PHOTO DEPICTS THE LABEL OF GRAM IODINE 212542, LOT NUMBER 5135629, EXPIRATION DATE 2026-11-30. SECOND PHOTO DEPICTS THE BOX WITH THE LABEL FOR GRAM CRYSTAL VIOLET 212525, LOT NUMBER 4344676, EXPIRATION DATE 2026-05-31. THIRD PHOTO DEPICTS THE BOX WITH THE LABEL FOR GRAM CRYSTAL VIOLET 212525, LOT NUMBER 5112529, EXPIRATION DATE 2026-10-31. FOURTH PHOTO DEPICTS THE BOX WITH THE LABEL FOR GRAM SAFRANIN 212531, NUMBER 5036302, EXPIRATION DATE 2026-08-31. THE LAST PHOTO DEPICTS TWO BOXES WITH LABELS FOR GRAM CRYSTAL VIOLET 212525, LOT NUMBERS 5112529, EXPIRATION DATE 2026-10-31 AND 5071499, EXPIRATION DATE 2026-08-31. A RETENTION SAMPLE FROM THE COMPLAINT BATCH, LOT NUMBER 4344676, WAS EVALUATED ALONG WITH A CONTROL BATCH OF CRYSTAL VIOLET. THE SOLUTION APPEARANCE OF RETENTION SAMPLE WAS SATISFACTORY AND COMPARABLE TO THE CONTROL; ALL WERE DEEP PURPLE SOLUTIONS WITH NO VISIBLE PRECIPITATE. SLIDES OF E. COLI ATCC 25922 AND S. AUREUS ATCC 25923 CONTROLS WERE EVALUATED AND HAD SATISFACTORY STAINING RESULTS FOR RETENTION AND CONTROL BATCHES. TEN FIELDS OF EACH SMEAR WERE EXAMINED IN DETAIL USING OIL IMMERSION LENS OF A LIGHT MICROSCOPE. NO EXCESSIVE PRECIPITATE, ARTIFACTS OR BACTERIAL CONTAMINATION WERE SEEN. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR CONTAMINATION.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2086296 | BD BBL¿ GRAM CRYSTAL VIOLET | STAINS, MICROBIOLOGIC | JTS | BECTON DICKINSON & CO. (SPARKS) | 4344676 | 30382902125250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |