BD BACTEC¿ MGIT¿ 960 PZA KIT
Report
- Report Number
- 1119779-2023-01191
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Date of Event
- October 19, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MJA
- UDI-DI
- 00382902451280
- PMA / PMN Number
- K021582
- Removal / Correction Number
- Z-2686-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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: D4. MEDICAL DEVICE LOT #: 2161925; D4. MEDICAL DEVICE EXPIRATION DATE: 25-OCT-2023; H4. DEVICE MANUFACTURE DATE: 10-JUN-2022. D4. MEDICAL DEVICE LOT #: 3122995; D4. MEDICAL DEVICE EXPIRATION DATE: 04-SEP-2024; H4. DEVICE MANUFACTURE DATE: 02-MAY-2023. E1. INITIAL REPORTER PHONE NUMBER: (B)(6); H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: BACTEC MGIT 960 PZA 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. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC MGIT 960 PZA 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. TWO BACTEC MGIT 960 PZA VIALS ARE THEN MANUALLY PACKAGED WITH SIX BACTEC MGIT 960 PZA SUPPLEMENT VIALS TO COMPLETE A BACTEC MGIT 960 PZA KIT (MATERIAL 245128). INVESTIGATION RESULTS FOR BATCH# 3122995: THE BATCH HISTORY RECORD REVIEW WAS SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING) OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING INTO THIS ISSUE. RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. THIS COMPLAINT IS CONFIRMED. A TREND IN PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR 245128 MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE RELATED TO BATCH 3122995. INVESTIGATION RESULTS FOR BATCH# 2161925: THE BATCH HISTORY RECORD WAS SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING) OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING INTO THIS ISSUE. RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. A TREND IN PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR 245128 MGIT PZA KIT. THIS COMPLAINT IS CONFIRMED BASED ON THE INCREASED TREND. BD HAS NOT INITIATED CORRECTIVE ACTION RELATED TO THIS BATCH AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 2161925. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR (B)(4).
IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ MGIT¿ 960 PZA KIT, FALSE RESISTANT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE RESISTANT RESULTS. CONFIRMATORY TESTING BY REPLICATION ON SOLID CULTURES AND SEQUENCING. CONTAMINATION WAS RULED OUT.
IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ MGIT¿ 960 PZA KIT, FALSE RESISTANT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE RESISTANT RESULTS. CONFIRMATORY TESTING BY REPLICATION ON SOLID CULTURES AND SEQUENCING. CONTAMINATION WAS RULED OUT.
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215798 | BD BACTEC¿ MGIT¿ 960 PZA KIT | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON, DICKINSON & CO. (SPARKS) | 3122995 | 00382902451280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |