BD BACTEC¿ MGIT¿ 960 SIRE KIT
Report
- Report Number
- 1119779-2022-00661
- Event Type
- Malfunction
- Date Received
- May 6, 2022
- Date of Event
- April 6, 2022
- Report Date
- August 15, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MJA
- UDI-DI
- 00382902451235
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1355594; MEDICAL DEVICE EXPIRATION DATE: 04/14/2022; DEVICE MANUFACTURE DATE: 12/21/2021; MEDICAL DEVICE LOT #: 1246434 ; MEDICAL DEVICE EXPIRATION DATE: 09/22/2022; DEVICE MANUFACTURE DATE: 09/03/2021. THERE WERE MULTIPLE PMA / 510K NUMBERS REPORTED TO BE INVOLVED: K003062, K014123. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6 INVESTIGATION SUMMARY : BATCH 1246434 MGIT 960 SIRE SUPPLEMENT KIT BATCH 1246434 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 1085448, MGIT 960 STREPTOMYCIN BATCH 1190553, MGIT 960 ISONIAZID BATCH 1190554, MGIT 960 RIFAMPIN BATCH 1190555 AND MGIT 960 ETHAMBUTOL BATCH 1190556. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT 960 SIRE 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 STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING 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 SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION. STREPTOMYCIN BATCH 1190553 (10/10 VIALS), ISONIAZID BATCH 119554 (10/10 VIALS), RIFAMPIN BATCH 1190555 (10/10 VIALS), ETHAMBUTOL BATCH 1190556 (10/10 VIALS), SIRE SUPPLEMENT BATCH 1085448 (8/8 VIALS). ALL VIALS HAVE BEEN MAINTAINED IN GOOD CONDITION. RETENTIONS WERE PERFORMANCE TESTED PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. FOR INVESTIGATION OF CONTAMINATION IN THE RETENTION SAMPLES, TWO ANTIBIOTICS FROM EACH BATCH WERE RECONSTITUTED WITH DISTILLED WATER THEN INCUBATED. ONE VIAL WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE VIAL WAS PLACED INTO 33-37-DEGREE DEGREE CELSIUS INCUBATION. TWO SUPPLEMENT VIALS WERE ALSO PLACED INTO INCUBATION. ONE SUPPLEMENT WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE SUPPLEMENT WAS PLACED INTO 33-37-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 10/10 INCUBATED RETENTION VIALS. BATCH 1130403 MGIT 960 SIRE SUPPLEMENT KIT BATCH 1130403 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 1064759, MGIT 960 STREPTOMYCIN BATCH 1072872, MGIT 960 ISONIAZID BATCH 1078725, MGIT 960 RIFAMPIN BATCH 1072874 AND MGIT 960 ETHAMBUTOL BATCH 1072875. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT 960 SIRE 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 STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING 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 SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION. HOWEVER, RETENTIONS WERE AVAILABLE FOR INVESTIGATION. STREPTOMYCIN BATCH 1072872 (10/10 VIALS), ISONIAZID BATCH 1078725 (10/10 VIALS), RIFAMPIN BATCH 1072874 (10/10 VIALS), ETHAMBUTOL BATCH 1072875 (10/10 VIALS), SIRE SUPPLEMENT BATCH 1064759 (6/6 VIALS). ALL VIALS HAVE BEEN MAINTAINED IN GOOD CONDITION. RETENTIONS WERE PERFORMANCE TESTED PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. FOR INVESTIGATION OF CONTAMINATION IN THE RETENTION SAMPLES, TWO ANTIBIOTICS FROM EACH BATCH WERE RECONSTITUTED WITH DISTILLED WATER THEN INCUBATED. ONE VIAL WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE VIAL WAS PLACED INTO 33-37-DEGREE DEGREE CELSIUS INCUBATION. TWO SUPPLEMENT VIALS WERE ALSO PLACED INTO INCUBATION. ONE SUPPLEMENT WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE SUPPLEMENT WAS PLACED INTO 33-37-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 10/10 INCUBATED RETENTION VIALS. BATCH 1355594 MGIT 960 SIRE SUPPLEMENT KIT BATCH 1355594 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 1301344, MGIT 960 STREPTOMYCIN BATCH 1287900, MGIT 960 ISONIAZID BATCH 1287901, MGIT 960 RIFAMPIN BATCH 1287902 AND MGIT 960 ETHAMBUTOL BATCH 1287903. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT 960 SIRE 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 STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING 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 SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION. STREPTOMYCIN BATCH 1287900 (10/10 VIALS), ISONIAZID BATCH 1287901 (10/10 VIALS), RIFAMPIN BATCH 1287902 (10/10 VIALS), ETHAMBUTOL BATCH 1287903 (10/10 VIALS), SIRE SUPPLEMENT BATCH 1301344 (10/10 VIALS). ALL VIALS HAVE BEEN MAINTAINED IN GOOD CONDITION. RETENTIONS WERE PERFORMANCE TESTED PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. FOR INVESTIGATION OF CONTAMINATION IN THE RETENTION SAMPLES, TWO ANTIBIOTICS FROM EACH BATCH WERE RECONSTITUTED WITH DISTILLED WATER THEN INCUBATED. ONE VIAL WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE VIAL WAS PLACED INTO 33-37-DEGREE DEGREE CELSIUS INCUBATION. TWO SUPPLEMENT VIALS WERE ALSO PLACED INTO INCUBATION. ONE SUPPLEMENT WAS PLACED INTO 20-25-DEGREE CELSIUS INCUBATION, AND ONE SUPPLEMENT WAS PLACED INTO 33-37-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 10/10 INCUBATED RETENTION VIALS. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR EITHER KIT BATCH FOR EITHER DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE AND CONTAMINATION ON ALL KIT BATCHES ASSOCIATED WITH THE COMPLAINT. SEE H10.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THE CUSTOMER OBSERVED CONTAMINATION IN THE TUBES AND THAT THERE WAS A FAILURE IN SUSCEPTIBILITY TESTING. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE VISIBLE GROWTH IN TUBES FOR AST AND MGIT FLAGGED THEM AS "R". REFERENCE METHOD PERFORMED BY NATIONAL REFERENCE CENTER FOR MYCOBACTERIOLOGY (PROPORTION METHOD) DOES NOT CONFIRM THE MGIT RESULT AND STRAINS ARE MARKED AS SUSCEPTIBLE FOR THE DIFFERENT TESTED ANTIBIOTICS."
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THE CUSTOMER OBSERVED CONTAMINATION IN THE TUBES AND THAT THERE WAS A FAILURE IN SUSCEPTIBILITY TESTING. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE VISIBLE GROWTH IN TUBES FOR AST AND MGIT FLAGGED THEM AS "R". REFERENCE METHOD PERFORMED BY NATIONAL REFERENCE CENTER FOR MYCOBACTERIOLOGY (PROPORTION METHOD) DOES NOT CONFIRM THE MGIT RESULT AND STRAINS ARE MARKED AS SUSCEPTIBLE FOR THE DIFFERENT TESTED ANTIBIOTICS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1098855 | BD BACTEC¿ MGIT¿ 960 SIRE KIT | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON, DICKINSON & CO. (SPARKS) | 245123 | 1130403 | 00382902451235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |