BD BBL¿ TB FLUORESCENT STAIN KIT M
Report
- Report Number
- 1119779-2025-04574
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Date of Event
- August 1, 2025
- Report Date
- December 5, 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 5085995, AND COMPLAINT #(B)(4) FOR CONTAMINATION. 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. TWO PHOTOS AND ONE SHORT VIDEO RECEIVED IN A LEU OF RETURN. THE FIRST PHOTO DEPICTS THE FRONT OF THE BOX WITH LABEL FOR TB FLUORESCENT STAIN KIT M 212519, BATCH NUMBER AND EXPIRATION DATE NOT VISIBLE. THE SECOND PHOTO DEPICTS THE HAND HOLDING THE BOTTLE WITH YELLOW SUSPENSION AND PART OF THE LABEL FOR PART NUMBER 212514 AND EXPIRATION DATE 2025-12-31, BATCH NUMBER NOT VISIBLE. THE SHORT VIDEO SHOWS A PERSON SHAKING THE BOTTLE WITH YELLOW SUSPENSION AND PART OF THE LABEL FOR PART NUMBER 212514 AND EXPIRATION DATE 2025-12-31, BATCH NUMBER NOT VISIBLE. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH NUMBER 5085995 OF TB STAIN KIT M PART NUMBER 212519, WAS EVALUATED ALONG WITH A CONTROL BATCH FOR SOLUTION APPEARANCE OF THE AURAMINE M COMPONENT PART NUMBER 212514, BATCH NUMBER 5001823 AND EXPIRATION DATE 2025-12-31. 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 WILL CONTINUE TO TREND DCM COMPLAINTS FOR CONTAMINATION. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT TECHNICAL SERVICES.
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 THERE WAS WHITE SEDIMENT AT THE BOTTOM OF THE AURAMINE VIAL OF THE KIT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED THERE WAS WHITE SEDIMENT AT THE BOTTOM OF THE AURAMINE VIAL OF THE KIT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247960 | BD BBL¿ TB FLUORESCENT STAIN KIT M | STAINS, MICROBIOLOGIC | JTS | BECTON DICKINSON & CO. (SPARKS) | 5085995 | 00382902125198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |