BD BACTEC¿ MGIT¿ 960 PZA KIT
Report
- Report Number
- 1119779-2024-00532
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- June 3, 2024
- 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
- TU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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). 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 REPORTED DEFECT. THIS COMPLAINT IS CONFIRMED. TREND IN PERFORMANCE COMPLAINTS IDENTIFIED FOR 245128 MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING A BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, SEVENTY-FIVE (75) FALSE RESISTANT RESULTS WERE OBTAINED. ADDITIONAL CONFIRMATORY TESTS WERE PERFORMED AND THE SAMPLES WERE SENT TO A LABORATORY AND REPEATED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, SEVENTY-FIVE (75) FALSE RESISTANT RESULTS WERE OBTAINED. ADDITIONAL CONFIRMATORY TESTS WERE PERFORMED AND THE SAMPLES WERE SENT TO A LABORATORY AND REPEATED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING A BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571690 | BD BACTEC¿ MGIT¿ 960 PZA KIT | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON DICKINSON & CO. (SPARKS) | 3241654 | 00382902451280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |