BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2025-00773
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 2, 2025
- Report Date
- September 8, 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
THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD DS SPARKS, MD LOCATION HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: REPORT 3 OF 5 IT WAS REPORTED WHILE USING ONE (1) BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE BIOLOGICAL CONTAMINATION WAS OBSERVED. THE TUBE FLAGGED POSITIVE IN LESS THAN FOUR (4) DAYS OF PROTOCOL ON THE BACTEC MGIT 960 ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. D1. MEDICAL DEVICE BRAND NAME: BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES. D4. MEDICAL DEVICE CATALOG #: 245122. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G4. PMA / 510(K)#: K974883.
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. CUSTOMER DID NOT PROVIDE A BATCH NUMBER, PHOTOS OR RETURNS FOR THIS COMPLAINT INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. A BATCH HISTORY REVIEW CANNOT BE PERFORMED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS PERFORMED ON THE APPROPRIATE QUALITY DATABASES AND NO TRENDS WERE FOUND IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 245122 AND THERE ARE NO TRENDS FOR CONTAMINATION IN ANY BATCH OVER THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND FOR THIS ISSUE. THIS COMPLAINT CANNOT BE CONFIRMED.
REPORT 3 OF 5. IT WAS REPORTED WHILE USING ONE (1) UNSPECIFIED BD BACTEC MGIT TUBE BIOLOGICAL CONTAMINATION WAS OBSERVED. THE TUBE FLAGGED POSITIVE IN LESS THAN FOUR (4) DAYS OF PROTOCOL ON THE BACTEC MGIT 960 ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
REPORT 3 OF 5. IT WAS REPORTED WHILE USING ONE (1) BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE BIOLOGICAL CONTAMINATION WAS OBSERVED. THE TUBE FLAGGED POSITIVE IN LESS THAN FOUR (4) DAYS OF PROTOCOL ON THE BACTEC MGIT 960 ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
REPORT 3 OF 5 IT WAS REPORTED WHILE USING ONE (1) BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE BIOLOGICAL CONTAMINATION WAS OBSERVED. THE TUBE FLAGGED POSITIVE IN LESS THAN FOUR (4) DAYS OF PROTOCOL ON THE BACTEC MGIT 960 ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11334 | BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | UNKNOWN | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |