BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2025-00046
- Event Type
- Malfunction
- Date Received
- February 7, 2025
- Date of Event
- January 14, 2025
- Report Date
- July 16, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382902451229
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: MATERIAL 245122 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD FOR BATCH 4060553 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. ROUTINE STABILITY STUDIES ARE PERFORMED ANNUALLY PER INTERNAL PROCEDURES FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS OF EACH PRODUCT. STABILITY DATA FOR THIS PRODUCT IS ON FILE. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 4060553. RETENTION SAMPLES FROM BATCH 4060553 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
THE INFORMATION FOR THE ADDITIONAL INITIAL REPORTER PHONE # IS AS FOLLOWS: E1. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, TWO (2) FALSE NEGATIVE RESULTS FOR M. TUBERCULOSIS WERE OBTAINED FROM THE MGIT960 ANALYZER. CONFIRMATORY TESTING OF THE SAMPLES INCLUDED REAL-TIME PCR ASSAY (CEPHEID GENEXPERT), CULTURING USING THE OGAWA-KUDOH METHOD, ZIEHL-NEELSEN STAINING, AND IMMUNOCHROMATOGRAPHY ASSAYS FOR MPT64 ANTIGEN ALL WITH POSITIVE M. TUBERCULOSIS RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, TWO (2) FALSE NEGATIVE RESULTS FOR M. TUBERCULOSIS WERE OBTAINED FROM THE MGIT960 ANALYZER. CONFIRMATORY TESTING OF THE SAMPLES INCLUDED REAL-TIME PCR ASSAY (CEPHEID GENEXPERT), CULTURING USING THE OGAWA-KUDOH METHOD, ZIEHL-NEELSEN STAINING, AND IMMUNOCHROMATOGRAPHY ASSAYS FOR MPT64 ANTIGEN ALL WITH POSITIVE M. TUBERCULOSIS RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247327 | BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 4060553 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |