BOTTLE TB AURAMINE M 250ML
Report
- Report Number
- 1119779-2021-01599
- Event Type
- Malfunction
- Date Received
- September 30, 2021
- Date of Event
- August 31, 2021
- Report Date
- November 8, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- KJK
- UDI-DI
- 00382902125143
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-20. H6: INVESTIGATION SUMMARY THE FOLLOWING SUMMARY IS IN RESPONSE AGAINST MATERIAL 212514, AND LOT 0288107 FOR PRECIPITATE DEFECTS. 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 REVIEW OF THE BATCH HISTORY RECORD TB AURAMINE M. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. SATISFACTORY APPEARANCE PER THE BD COA 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. THE RETURN RECEIVED ON 09/20/21. THE RETURN BOTTLE WAS PREVIOUSLY OPENED AND ALMOST EMPTY. THE RETURN AND RETENTION SAMPLES FROM THE COMPLAINT BATCH WERE EVALUATED ALONG WITH A CONTROL BATCH OF TB AURAMINE M. THERE WAS A LARGE AMOUNT OF PARTICULATE VISIBLE IN THE RETURN AND RETENTION SAMPLES AS WELL AS THE CONTROL. 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 RETURN, RETENTION AND CONTROL BATCHES. THE RETURN AND RETENTION SAMPLES WERE COMPARABLE TO THE CONTROL. THE PRESENCE OF THE PARTICLES IS NOT CONSIDERED A PRODUCT DEFECT FOR TB AURAMINE, AS THEY ARE EXPECTED TO BE PRESENT WITHIN THE SUSPENSION, AND ALLOWABLE PER CLAIMS ON THIS PRODUCT. CONSEQUENTLY, THIS COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BOTTLE TB AURAMINE M 250ML EXPERIENCED BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED SEDIMENTS/PRECIPITATES IN THEIR BOTTLE OF TB AURAMINE M STAIN FROM LOT 0288107, EXP: 2021-10-31 (CAT# 212514). THEY ARE USING THE TB FLUORESCENT STAIN KIT M FOR THE MORSE COLORATION. SHE DIDN¿T PROVIDE THE STAIN KIT LOT NUMBER.
IT WAS REPORTED THAT THE BOTTLE TB AURAMINE M 250ML EXPERIENCED BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED SEDIMENTS/PRECIPITATES IN THEIR BOTTLE OF TB AURAMINE M STAIN FROM LOT 0288107, EXP: 2021-10-31 (CAT# 212514). THEY ARE USING THE TB FLUORESCENT STAIN KIT M FOR THE MORSE COLORATION. SHE DIDN¿T PROVIDE THE STAIN KIT LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449576 | BOTTLE TB AURAMINE M 250ML | SYSTEM, BLOOD CULTURING | KJK | BECTON, DICKINSON & CO. (SPARKS) | 212514 | 0288107 | 00382902125143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |