BD BACTEC¿ MGIT¿ 960 PZA MEDIUM
Report
- Report Number
- 1119779-2024-00112
- Event Type
- Malfunction
- Date Received
- February 15, 2024
- Date of Event
- January 25, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MJA
- UDI-DI
- 30382902451151
- PMA / PMN Number
- K021582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3025516 D.4. MEDICAL DEVICE EXPIRATION DATE: 27-JUL-2024 H.4. DEVICE MANUFACTURE DATE: 25-JAN-2023 D.4. MEDICAL DEVICE LOT #: 3110188 D.4. MEDICAL DEVICE EXPIRATION DATE: 19-OCT-2024 H.4. DEVICE MANUFACTURE DATE: 20-APR-2023.
INVESTIGATION SUMMARY: MATERIAL 245115 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BD MGIT PZA TESTING SYSTEM CONSISTS OF MGIT PZA 7ML TUBES (MATERIAL 245115) AND THE MGIT PZA DRUG KIT (MATERIAL 245128). THE MGIT PZA DRUG KIT CONSISTS OF LYOPHILIZED PZA DRUG AND LIQUID PZA SUPPLEMENT COMPONENTS. THE PZA DRUG, PZA SUPPLEMENT AND PZA 7ML TUBES ARE USED TOGETHER TO PERFORM PZA TESTING IN THE BD BACTEC MGIT INSTRUMENTS. A COMPLAINT TREND FOR PERFORMANCE WAS IDENTIFIED INVOLVING 245115 AND 245128 MGIT PZA KIT BATCHES. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE. THE INVESTIGATION HAS RULED OUT MGIT PZA 7ML TUBES (MATERIAL 245115) AS THE CAUSE OF INCREASED, INTERMITTENT FALSE RESISTANCE RESULTS OBSERVED. THE BATCH HISTORY RECORD REVIEW IS SATISFACTORY FOR THE INCIDENT LOTS. 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). RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. BECAUSE THE MGIT PZA 7ML TUBES WERE RULED OUT BY THE CAPA INVESTIGATION AND RETENTION SAMPLE TESTING HAS NOT REPLICATED THE FALSE RESISTANCE, THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3025516. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, 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 11910483.
IT WAS REPORTED WHEN USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM THAT FALSE RESISTANCE WAS OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM THAT FALSE RESISTANCE WAS OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, 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 |
|---|---|---|---|---|---|---|---|
| 462760 | BD BACTEC¿ MGIT¿ 960 PZA MEDIUM | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON DICKINSON & CO. (SPARKS) | SEE H.10 | 30382902451151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |