BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2024-00492
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- May 9, 2024
- Report Date
- August 14, 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
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, FALSE NEGATIVE RESULTS WERE OBTAINED. AFTER VISUAL INSPECTION OF SOME FALSE NEGATIVE TUBES, "CRUMBLING MATTER" COULD BE OBSERVED AT THE BOTTOM. IN ADDITION, THE FALSE NEGATIVE TUBES WERE POSITIVE UNDER UV LIGHT AND AFTER CULTURING. THIS EVENT OCCURRED THREE (3) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. D.1. MEDICAL DEVICE BRAND NAME: BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES D.4. MEDICAL DEVICE CATALOG #: 245122. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.4. MEDICAL DEVICE LOT #: 3234911. D.4. MEDICAL DEVICE EXPIRATION DATE: 08-FEB-2025. G.4. PMA/510(K)#: K974883. H.4. DEVICE MANUFACTURE DATE: 22-AUG-2023.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN LOT NUMBER D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
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: 3234911 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: 3234911 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 WERE NO PHOTOS OR RETURN SAMPLES RECEIVED TO ASSIST WITH THE INVESTIGATION. RETENTION SAMPLE TESTING OF THE BATCH IN QUESTION WAS SATISFACTORY. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHEN USING THE BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, FALSE NEGATIVE RESULTS WERE OBTAINED. AFTER VISUAL INSPECTION OF SOME FALSE NEGATIVE TUBES, "CRUMBLING MATTER" COULD BE OBSERVED AT THE BOTTOM. IN ADDITION, THE FALSE NEGATIVE TUBES WERE POSITIVE UNDER UV LIGHT AND AFTER CULTURING. THIS EVENT OCCURRED THREE (3) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), FALSE NEGATIVE RESULTS WERE OBTAINED. AFTER VISUAL INSPECTION OF SOME FALSE NEGATIVE TUBES, "CRUMBLING MATTER" COULD BE OBSERVED AT THE BOTTOM. IN ADDITION, THE FALSE NEGATIVE TUBES WERE POSITIVE UNDER UV LIGHT AND AFTER CULTURING. THIS EVENT OCCURRED THREE (3) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, FALSE NEGATIVE RESULTS WERE OBTAINED. AFTER VISUAL INSPECTION OF SOME FALSE NEGATIVE TUBES, "CRUMBLING MATTER" COULD BE OBSERVED AT THE BOTTOM. IN ADDITION, THE FALSE NEGATIVE TUBES WERE POSITIVE UNDER UV LIGHT AND AFTER CULTURING. THIS EVENT OCCURRED THREE (3) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1437016 | BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 3234911 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |