BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Report
- Report Number
- 1119779-2025-00013
- Event Type
- Malfunction
- Date Received
- January 22, 2025
- Date of Event
- December 27, 2024
- Report Date
- April 23, 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
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY - MGIT 960 SUPPLEMENT KIT BATCH 4193327 IS COMPOSED OF MGIT PANTA BATCH 4193325 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4193326. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4193327 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. 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 REVIEWS FOR MGIT PANTA BATCH 4193325 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4193326 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE CRIMPED APPROPRIATELY PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON EITHER BATCH. RETENTIONS ARE AVAILABLE FOR THIS INVESTIGATION (6 VIALS OF 4193326 AND 12 VIALS OF 4193325). ALL VIALS WERE INSPECTED, NONE OF THE VIALS APPEARED TO BE CONTAMINATED OR HAVE FOREIGN MATTER. 2 PAIRS OF THE VIALS WERE RECONSTITUTED AND INCUBATED FOR 14 DAYS (1 PAIR IN 23-27 DEGREE C AND THE OTHER IN 33-37). NO GROWTH/CONTAMINATION WAS OBSERVED. 1 PHOTO WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS A VIAL WITH CONTAMINANT SETTLED AT THE BOTTOM OF THE VIAL. THE BATCH DETAILS CANNOT BE VERIFIED IN THIS PHOTO. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
E1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS OBSERVED TO HAVE BIOLOGICAL CONTAMINATION DESCRIBED AS A FOREIGN OBJECT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS OBSERVED TO HAVE BIOLOGICAL CONTAMINATION DESCRIBED AS A FOREIGN OBJECT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650875 | BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 4193327 | 00382902451242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |