BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2025-04389
- Event Type
- Malfunction
- Date Received
- August 26, 2025
- Date of Event
- January 2, 2025
- Report Date
- October 1, 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
- SP
- 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 REVIEW FOR BATCH 4151584 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, TORQUING, AND FILLING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES. THOSE CHECKS ALSO CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED AND NO OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 4151584 FOR PERFORMANCE ISSUES. THE RETENTION SAMPLES WERE AVAILABLE FOR INSPECTION. RETENTION SAMPLES WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY PER THE BD STANDARD PERFORMANCE PROTOCOL FOR MATERIAL 245122. ALL ORGANISMS TESTED FOR GROWTH, AS LISTED IN THE CERTIFICATE OF ANALYSIS, HAD DETECTIBLE GROWTH IN THE INSTRUMENT WITHIN THE EXPECTED INCUBATION TIME. ADDITIONALLY, ANTIBIOTIC SUSCEPTIBILITY TESTING WAS SATISFACTORY WITH DETECTIBLE GROWTH CONTROLS AND EXPECTED SUSCEPTIBILITY RESULTS FOR THE ORGANISMS AGAINST THE DRUGS TESTED. THERE WERE NO PHOTOS OR RETURNS RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
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 WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. UPON PERFORMING CONFIRMATORY TESTING WITH LOWENSTEIN-JENSEN MEDIA, A POSITIVE RESULT WAS OBTAINED. THE ERRONEOUS FALSE NEGATIVE RESULT WAS NOT REPORTED TO A PHYSICIAN. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. UPON PERFORMING CONFIRMATORY TESTING WITH LOWENSTEIN-JENSEN MEDIA, A POSITIVE RESULT WAS OBTAINED. THE ERRONEOUS FALSE NEGATIVE RESULT WAS NOT REPORTED TO A PHYSICIAN. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2609314 | BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 4151584 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |