BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Report
- Report Number
- 1119779-2022-00081
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- January 5, 2022
- Report Date
- August 25, 2022
- 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
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES., D9: RETURNED TO MANUFACTURER ON: 14-JAN-2022. H.6 INVESTIGATION SUMMARY: MGIT PANTA BATCH NUMBER 1161152 AND MGIT 960 GROWTH SUPPLEMENT BATCH NUMBER 1154511 WERE PROVIDED FOR INVESTIGATION. REVIEW OF THE MANUFACTURING RECORDS FOR THESE TWO COMPONENTS SHOW THEY WERE PACKAGED INTO MGIT 960 SUPPLEMENT KIT BATCH NUMBER 1161188. SHIPPING RECORDS FOR KIT BATCH NUMBER 1161188 DOES SHOW A QUANTITY WAS SHIPPED TO JAPAN. THIS COMPLAINT CAN BE INVESTIGATED FOR KIT BATCH 1161188. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 1161188 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 1161152 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1154511WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM PANTA BATCH 1161152 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED FROM VISUAL INSPECTION OF 10/10 RETENTION VIALS. RETENTION SAMPLES FROM GROWTH SUPPLEMENT BATCH 1154511 (6 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED IN 6/6 RETENTION SAMPLES FROM VISUAL INSPECTION. FOR INVESTIGATION OF THE COMPLAINT, ONE PANTA RETENTION VIALS WAS RECONSTITUTED WITH ONE GROWTH SUPPLEMENT RETENTION VIAL AS PER THE PACKAGE INSERT INSTRUCTIONS FOR THIS KIT PRODUCT AND INCUBATED AT 20 TO 25 DEGREES C. ANOTHER PANTA RETENTION VIAL WAS RECONSTITUTED WITH ONE GROWTH SUPPLEMENT RETENTION VIAL AND INCUBATED AT 33 TO 37 DEGREES C. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED IN THE VIALS INCUBATED. RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE PANTA VIAL FROM BATCH 1161152 AND ONE GROWTH SUPPLEMENT VIAL FROM BATCH 1154511 IN A PLASTIC BAG WERE RETURNED IN A BOX WITH BUBBLE WRAP. THE CRIMP CAP AROUND THE STOPPERS OF THE VIALS WERE NOT PRESENT. THERE WAS MEDIA PRESENT IN THE GROWTH SUPPLEMENT VIAL BUT NO MICROBIAL GROWTH WAS OBSERVED. THE PANTA MEDIA WAS RECONSTITUTED AND THERE WAS FUNGAL GROWTH IN THE MEDIAL. THE PANTA VIAL WAS SUBMITTED TO THE ID LAB AND THE FUNGAL GROWTH WAS IDENTIFIED AS TRICHOPHYTON SPECIES. SIX PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION: --ONE PHOTO SHOWS ONE GROWTH SUPPLEMENT VIAL FROM BATCH 1154511 WITHOUT A CRIMP CAP AND ONE PANTA VIAL FROM BATCH 1161152 WITHOUT A CRIMP AROUND THE STOPPER AS WELL. --ONE PHOTO SHOWS ONE GROWTH SUPPLEMENT VIAL WITHOUT A CRIMP AROUND THE STOPPER AND ONE PANTA VIAL WITHOUT A CRIMP. --THREE PHOTOS EACH SHOW A CLOSE-UP OF RECONSTITUTED MEDIA IN A VIAL WITH WHAT APPEARS TO BE FUNGAL GROWTH FEATURED IN THE MEDIA. --ONE PHOTO FEATURES A VIAL LABEL FROM BATCH 1161152 FOR BATCH VERIFICATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A COMPLAINT TREND FOR CONTAMINATION WAS IDENTIFIED ON KIT BATCH 1161188. INVESTIGATION OF THE TREND FOUND MOLD FROM ENVIRONMENTAL MONITORING DURING PRODUCTION OF GROWTH SUPPLEMENT BATCH 1154511. THE MOLD OBSERVED DURING ENVIRONMENTAL MONITORING DID NOT EXCEED LEVELS TO TRIGGER AN ACTION PER BD PROCEDURES. DUE TO THE COMPLAINT TREND, MANUFACTURING OPERATIONS INVESTIGATED THE OBSERVED MOLD AND DID NOT FIND A ROOT CAUSE. MANUFACTURING OPERATIONS CONDUCTED A RETRAINING EVENT WITH MANUFACTURING ASSOCIATES FOR ASEPTIC TECHNIQUE AND IN-PROCESS BIOBURDEN REDUCTION AS A CORRECTIVE ACTION. MANUFACTURING OPERATIONS ALSO IDENTIFIED OPPORTUNITIES FOR IMPROVEMENT THAT ARE BEING INVESTIGATED AS WELL. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAS BEEN FOUND CONTAINING FOREIGN MATTER. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND FOREIGN MATTER WHEN MIXING OADC INTO THE SUPPLEMENT. AFTER MIXING THEM, FLOATING MOLD-LIKE MATTER WAS NOTICED.
IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAS BEEN FOUND CONTAINING FOREIGN MATTER. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND FOREIGN MATTER WHEN MIXING OADC INTO THE SUPPLEMENT. AFTER MIXING THEM, FLOATING MOLD-LIKE MATTER WAS NOTICED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554755 | BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 245124 | UNKNOWN | 00382902451242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |