BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Report
- Report Number
- 1119779-2025-00461
- Event Type
- Malfunction
- Date Received
- May 21, 2025
- Date of Event
- April 20, 2025
- Report Date
- June 30, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 00382902451242
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE LOT#: 4213716 WAS REPORTED; HOWEVER, THIS IS NOT A KIT LOT # MANUFACTURED FOR THE REPORTED CATALOG #. UPDATED TO UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN 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: D4. MEDICAL DEVICE LOT #: 4242981. D4. MEDICAL DEVICE EXPIRATION DATE: 10-DEC-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 29-AUG-2024.
INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4242981 IS COMPOSED OF MGIT PANTA BATCH 4213716 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4159925. MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4242981 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 4213716 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4159925 WERE ALSO SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT WAS TAKEN ON KIT BATCH 4242981. THE RETENTION SAMPLES FOR THIS KIT BATCH WERE NOT AVAILABLE TO ASSIST WITH THIS COMPLAINT. FIVE PHOTOS WERE RECEIVED TO ASSIST WITH THIS INVESTIGATION. ONE PHOTO SHOWED A PLATE WITH WHITE GROWTHS. ONE PHOTO SHOWED A 100PK TUBE TRAY WITH TUBES. ONE PHOTO SHOWED CARTON LABEL 4242981 EXP 2025-12-10. TWO PHOTOS SHOWED RECONSTITUTED PANTA VIAL (BATCH 4213716 EXP 2026-02-01) WITH WHITE MASSES FLOATING IN THE MEDIA. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION FROM THE PHOTOS RECEIVED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS FOUND TO BE CONTAMINATED UPON MACROSCOPIC INSPECTION. IN ADDITION, THE MEDIA LIQUID WAS SUBCULTURED AND MOLD WAS OBSERVED UPON INCUBATION ON THE CULTURE DISH. AFTER DETECTING THE MOLD CONTAMINATION, TESTING WAS TERMINATED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS FOUND TO BE CONTAMINATED UPON MACROSCOPIC INSPECTION. IN ADDITION, THE MEDIA LIQUID WAS SUBCULTURED AND MOLD WAS OBSERVED UPON INCUBATION ON THE CULTURE DISH. AFTER DETECTING THE MOLD CONTAMINATION, TESTING WAS TERMINATED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS FOUND TO BE CONTAMINATED UPON MACROSCOPIC INSPECTION. IN ADDITION, THE MEDIA LIQUID WAS SUBCULTURED AND MOLD WAS OBSERVED UPON INCUBATION ON THE CULTURE DISH. AFTER DETECTING THE MOLD CONTAMINATION, TESTING WAS TERMINATED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724296 | BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 4242981 | 00382902451242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |