BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2025-00297
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- March 27, 2025
- Report Date
- June 23, 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
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES D9. RETURNED TO MANUFACTURER ON: 08-APR-2025 H3. DEVICE EVAL BY MANUFACTURER- YES 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 4221364 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES WERE NOT INSPECTED DUE TO THE NATURE OF THIS COMPLAINT. THERE WERE FOUR (4) PHOTOS SUBMITTED TO ASSIST WITH THIS COMPLAINT. THE PHOTOS SHOW BATCH VERIFICATION FOR BATCH 4221364 WITH EXPIRATION 2026-02-04. THE PHOTOS ALSO SHOW TUBES WITH SEDIMENT. THERE WERE 92 TUBES RETURNED TO PROVIDE ASSISTANCE WITH THIS INVESTIGATION. THE RETURNED TUBES ALL HAD ABOUT THE SAME AMOUNT OF PRECIPITATE IN THE TUBE. FIVE (5) TUBES WERE INCUBATED AT EACH 20-25C AND 33-37C FOR 5 DAYS. AT THE COMPLETION OF INCUBATION THERE WAS NO GROWTH. A CULTURE OF THE SEDIMENT WAS PLACED IN A TSB TUBE AND INCUBATED AT 33-37C FOR 7 DAYS. THERE WAS NO GROWTH AFTER 7 DAYS OF INCUBATION IN THE TSB. A GRAM STAIN WAS PERFORMED AND THE PRECIPITATE SHOWED GRAM VARIABLE COCCI, THUS THE PRECIPITATE WAS NON-VIABLE ORGANISMS. MANUFACTURING HAS BEEN MADE AWARE OF THE ISSUE AND A CROSS FUNCTIONAL TEAM WILL SEEK OPPORTUNITIES FOR IMPROVEMENT. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE CONTAMINATION DESCRIBED AS "WHITE SEDIMENT" IN THE BOTTOM OF THE MEDIA. THE CONTAMINATED TUBES WERE NOT USED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE CONTAMINATION DESCRIBED AS "WHITE SEDIMENT" IN THE BOTTOM OF THE MEDIA. THE CONTAMINATED TUBES WERE NOT USED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560462 | BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 4221364 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |