BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Report
- Report Number
- 1025402-2023-00003
- Event Type
- Malfunction
- Date Received
- March 17, 2023
- Date of Event
- March 7, 2023
- Report Date
- April 6, 2023
- Manufacturer
- LEE LABORATORIES, INC.
- 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
INITIAL REPORTER PHONE: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY : MGIT 960 SUPPLEMENT KIT IS COMPOSED OF TWO COMPONENTS: MGIT PANTA AND MGIT GROWTH SUPPLEMENT. 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). PANTA BATCH NUMBER 2181198 WAS PROVIDED FOR INVESTIGATION. THE BATCH HISTORY RECORD REVIEW FOR PANTA BATCH 2181198 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE RECONSTITUTED AND ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR 14 DAYS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. RETENTION SAMPLES FROM PANTA BATCH 2181198 (10 VIALS) WERE AVAILABLE FOR INSPECTION. MICROBIAL GROWTH WAS NOT OBSERVED IN 10/10 VIALS FROM VISUAL INSPECTION. FOR INVESTIGATION OF THIS COMPLAINT, RETENTION SAMPLES WERE TESTED: PANTA ALONE: TWO RETENTION PANTA VIALS WERE RECONSTITUTED WITH DISTILLED WATER AND INCUBATED AT 20 TO 25 DEGREES C (1 VIAL) AND 33 TO 37 DEGREES C (1 VIAL). PANTA RECONSTITUTED WITH SUPPLEMENT: TWO RETENTION PANTA VIALS WERE RECONSTITUTED WITH TWO RETENTION GROWTH SUPPLEMENT VIALS. ONE RECONSTITUTED PANTA VIAL AND THE GROWTH SUPPLEMENT VIAL WITH REMAINING MEDIA WERE INCUBATED AT 20 TO 25 DEGREES C AND THE OTHER RECONSTITUTED PANTA VIAL AND GROWTH SUPPLEMENT VIAL WITH REMAINING MEDIA WERE INCUBATED AT 33 TO 37 DEGREES C. NO MICROBIAL GROWTH WAS OBSERVED IN THE TESTED RETENTION VIALS AT 14 DAYS INCUBATION. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. HOWEVER, TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. EACH PHOTO SHOWS A RECONSTITUTED PANTA VIAL FROM BATCH 2181198. THE CRIMP CAP HAS BEEN REMOVED AND THERE APPEARS TO BE FUNGAL GROWTH IN EACH VIAL. NO 245124 KIT BATCH NUMBER WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. HOWEVER, MANUFACTURING RECORDS FOR PANTA BATCH 2181198 WERE REVIEWED AND A PROBABLE KIT BATCH NUMBER WAS IDENTIFIED. A COMPLAINT TREND WAS IDENTIFIED FOR CONTAMINATION INVOLVING COMPONENT PANTA BATCH 2181198. THE COMPONENT WAS PACKAGED INTO A KIT THAT WAS KNOWN TO BE DISTRIBUTED IN CHINA. INVESTIGATION OF THE TREND FOUND AN INTERVENTION DURING FILLING OF A COMPONENT THAT REQUIRED OPERATOR INTERVENTION. THE INTERVENTION WAS FOR A MECHANICAL ISSUE THAT HAS BEEN IMPROVED SINCE PRODUCTION OF THIS BATCH. BD EXPECTS THE NEED FOR INTERVENTIONS DURING THE FILLING PROCESS FOR THIS PRODUCT TO BE REDUCED GOING FORWARD. ANY OPERATOR INTERVENTIONS DURING MANUFACTURING HAVE THE POTENTIAL TO INTRODUCE CONTAMINANTS DESPITE ENGINEERED PROCESSES AND PRECAUTIONS. WHILE AN INTERVENTION WAS IDENTIFIED AND HAS BEEN IMPROVED UPON, AN EXACT ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE DETERMINED FOR THE CONTAMINATION IN THIS BATCH. AN AWARENESS TRAINING WITH MANUFACTURING OPERATIONS WAS CONDUCTED ABOUT THE RISK OF INTRODUCING CONTAMINANTS DURING AN INTERVENTION BECAUSE OF THIS TREND. THIS COMPLAINT CAN BE CONFIRMED BY THE TREND. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION HAS BEEN FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE'S CONTAMINATION IN THE OADC.
IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION HAS BEEN FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE'S CONTAMINATION IN THE OADC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547456 | BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | LEE LABORATORIES, INC. | 245124 | UNKNOWN | 00382902451242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |