BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2024-00951
- Event Type
- Malfunction
- Date Received
- December 4, 2024
- Date of Event
- October 21, 2024
- Report Date
- April 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
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
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 AND INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 4221364 WERE AVAILABLE FOR INSPECTION. RETENTION SAMPLES WERE PERFORMANCE TESTED FOR GROWTH 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. THERE WAS ONE CUSTOMER QUALITY CONTROL LOG PROVIDED SUBMITTED AS A PHOTO FOR THIS COMPLAINT. THE CUSTOMER QUALITY CONTROL LOG INDICATES THE BATCH IN QUESTION, 4221364, IS ACCEPTABLE. THERE WERE NO RETURNS AVAILABLE FOR REVIEW TO ASSIST WITH THIS COMPLAINT. RETENTION SAMPLE TESTING OF THE BATCH IN QUESTION WAS SATISFACTORY. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF FALSE POSITIVE STERILE BODY FLUID PATIENT AND QC SAMPLES WERE OBTAINED. UPON USING KINYOUN STAIN, 7H11 MEDIA, PCR TESTING, AND RETESTING ON A SECOND INSTRUMENT NEGATIVE RESULTS FOR THE PATIENT SAMPLES WERE OBTAINED. IN ADDITION, NEGATIVE QC SAMPLES PASSED. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF FALSE POSITIVE STERILE BODY FLUID PATIENT AND QC SAMPLES WERE OBTAINED. UPON USING KINYOUN STAIN, 7H11 MEDIA, PCR TESTING, AND RETESTING ON A SECOND INSTRUMENT NEGATIVE RESULTS FOR THE PATIENT SAMPLES WERE OBTAINED. IN ADDITION, NEGATIVE QC SAMPLES PASSED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2050540 | 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 |