BD BBL¿ TB FLUORESCENT STAIN KIT M
Report
- Report Number
- 1119779-2025-03516
- Event Type
- Malfunction
- Date Received
- August 18, 2025
- Date of Event
- July 23, 2025
- Report Date
- October 7, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JTS
- UDI-DI
- 00382902125198
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO KIT TB FLUORESCENT STAIN KIT M, CATALOG NUMBER 212519, BATCH 5049908, AND COMPLAINT #(B)(4) FOR CONTAMINATION. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING THE PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD TB STAIN KIT M. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL THE RELEASE TESTING WAS SATISFACTORY. SATISFACTORY APPEARANCE FOR AURAMINE M COMPONENT IS ¿YELLOW SUSPENSION¿. BY DEFINITION A SUSPENSION IS ¿A MIXTURE IN WHICH PARTICLES ARE DISPERSED THROUGHOUT THE BULK OF THE FLUID¿. IT IS ALSO DEFINED AS ¿A MIXTURE IN WHICH ALL PARTICLES OF A SUBSTANCE ARE DISPERSED THROUGHOUT A GAS OR LIQUID. IF A SUSPENSION IS LEFT UNDISTURBED, THE PARTICLES ARE LIKELY TO SETTLE TO THE BOTTOM. THE PARTICLES IN A SUSPENSION ARE LARGER THAN THOSE IN EITHER A COLLOID OR A SOLUTION¿. 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. THREE PHOTOS AND ONE SHORT VIDEO RECEIVED IN A LEU OF RETURN. THE ONE PHOTO DEPICTS A MICROSCOPIC VIEW OF A YELLOW GREEN BACKGROUND WITH YELLOW, FLUORESCENT CLUMPS. THE SECOND PHOTO DEPICTS THE FRONT OF THE BOX WITH LABEL FOR TB FLUORESCENT STAIN KIT M 212519, LOT NUMBER 5049908, EXPIRATION DATE 2025-12-31. THE THIRD PHOTO DEPICTS THE HAND HOLDING THE BOTTLE WITH YELLOW SUSPENSION OF AURAMINE M 212514, LOT NUMBER 5001823, EXPIRATION DATE 2025-12-31. THE SHORT VIDEO SHOWS A PERSON INVERTING THE BOTTLE WITH YELLOW SUSPENSION AND LABEL NOT VISIBLE. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH OF TB STAIN KIT M, WAS EVALUATED ALONG WITH A CONTROL BATCH FOR SOLUTION APPEARANCE AND PERFORMANCE. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF POSITIVE (M. TUBERCULOSIS ATCC 25177) AND NEGATIVE (B. SUBTILIS ATCC 6533) CONTROLS WERE EVALUATED AND GAVE SATISFACTORY STAINING RESULTS WITH THE RETENTION AND CONTROL BATCHES. THE SOLUTION APPEARANCE OF THE RETENTION SAMPLE FOR AURAMINE M COMPONENT FROM THE KIT WAS COMPARABLE TO THE CONTROL AND WAS A YELLOW SUSPENSION. THE PRECIPITATE IN QUESTION IS INHERENT TO THE STAIN AND DOES NOT AFFECT THE PERFORMANCE OF THE STAIN. THIS COMPLAINT IS NOT CONFIRMED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.
H3: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED WHITE SEDIMENTATION AND CRYSTALS IN THE MICROSCOPY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED WHITE SEDIMENTATION AND CRYSTALS IN THE MICROSCOPY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1762625 | BD BBL¿ TB FLUORESCENT STAIN KIT M | STAINS, MICROBIOLOGIC | JTS | BECTON DICKINSON & CO. (SPARKS) | 5049908 | 00382902125198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |