BD BACTEC MGIT 960 SYSTEM
Report
- Report Number
- 1119779-2020-00208
- Event Type
- Malfunction
- Date Received
- July 14, 2020
- Date of Event
- June 22, 2020
- Report Date
- July 22, 2020
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- MDB
- UDI-DI
- 00382904458706
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: THE COMPLAINT WAS CREATED FOR A CONTAMINATION EVENT ON THE BACTEC MGIT 960 INSTRUMENT (P/N 445870, S/N (B)(6)). THE CUSTOMER REPORTED A POSITIVE VIAL LEAKED FLUID FROM THE MGIT TUBE AND INTO THE INSTRUMENT. NO ERRORS WERE DISPLAYED ON THE INSTRUMENT. THE VIAL WAS IN THE INSTRUMENT FOR 11 DAYS (PROTOCOL STARTED ON JUNE 11, 2020). THE CUSTOMER DID NOT NOTICED ANY CRACKS AT THE TIME OF THE LOGGING IN THE VIAL. THE CUSTOMER IS NOT AWARE OF ANYONE HANDLING THE VIAL IN BETWEEN THE START OF PROTOCOL AND THE TIME TO POSITIVITY. WHEN SCANNING OUT THE POSITIVE VIAL, THE CUSTOMER NOTICED THE VIAL WAS NOT FILLED TO THE 7ML VOLUME. THAT IS WHEN THE CUSTOMER WAS AWARE OF THE SPILL IN THE DRAWER. THE CUSTOMER NOTED THE CRACK WAS VERY SLIGHT, JUST ENOUGH FOR LIQUID TO ESCAPE FROM THE VIAL, BUT NO JAGGED EDGES OR BROKEN PIECES OF GLASS. THE CUSTOMER WAS NOT EXPOSED AS THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THE VIAL WAS NOT WET. THE VIAL IS POSITIVE FOR M KANSASII. AT THAT POINT, THE CUSTOMER CLOSED THE INSTRUMENT DOOR AND CALLED BD FOR DECONTAMINATION INSTRUCTIONS. BD RESEARCH AND DEVELOPMENT RECOMMENDED IF THERE IS NO EVIDENCE OR RECORD OF A SPILL WITHIN THE UNIT, THOROUGHLY SPRAY AND WIPE DOWN THE INSTRUMENT WITH AN APPROVED TUBERCULOCIDAL DISINFECTANT; INCLUDING THE DRAWERS AND THE OUTSIDE OF THE INSTRUMENT. IF THERE IS A SPILL WITHIN THE INSTRUMENT, THE INSTRUMENT SHOULD BE POWERED OFF AND THE ENTIRE INSTRUMENT SHOULD BE DECONTAMINATED BY VAPOR PHASE HYDROGEN PEROXIDE PROCESS. TURNING OFF THE INSTRUMENT WOULD DECREASE THE RISK OF AEROSOLIZATION FROM THE INSTRUMENT FAN SYSTEM. THE CUSTOMER WILL PERFORM THE VAPOR PHASE HYDROGEN PEROXIDE DECONTAMINATION. THE INSTRUMENT IS POWER DOWN AND UNUSED WHILE AWAITING FOR DECONTAMINATION. THE BD BACTEC MGIT INSTRUMENT USER¿S MANUAL (MA0117 REV 16, SECTION 6.2.3.5) STATED: ¿IN THE EVENT OF TUBE LEAKAGE OR BREAKAGE: 1) CLOSE THE INSTRUMENT DRAWERS; 2) TURN OFF THE INSTRUMENT; 3) VACATE THE AREA IMMEDIATELY; 4) CONSULT YOUR FACILITY/CDC GUIDELINES. AN INOCULATED LEAKING OR BROKEN TUBE MAY PRODUCE AN AEROSOL OF MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED.¿ THE PACKAGE INSERT FOR BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE 7 ML WITH BD BACTEC MGIT 960 SUPPLEMENT KIT (L000180JAA) STATED ¿PRIOR TO USE, EACH MGIT TUBE SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION OR DAMAGE. DISCARD ANY TUBES IF THEY APPEAR UNSUITABLE. DROPPED TUBES SHOULD BE EXAMINED CAREFULLY. IF DAMAGE IS SEEN, THE TUBE SHOULD BE DISCARDED. IN THE EVENT OF TUBE BREAKAGE: 1) CLOSE THE INSTRUMENT DRAWERS; 2) TURN OFF THE INSTRUMENT; 3) VACATE THE AREA IMMEDIATELY; 4) CONSULT YOUR FACILITY/CDC GUIDELINES. AN INOCULATED LEAKING OR BROKEN VIAL MAY PRODUCT AN AEROSOL OF MYCOBACTERIA; APPROPRIATE HANDING SHOULD BE OBSERVED.¿ A REVIEW OF THE SERVICE HISTORY FOR INSTRUMENT SERIAL NUMBER (B)(6) SHOWED THERE WERE NO FURTHER COMPLAINTS REGARDING THIS ISSUE, NOR WAS THERE ANY PRIOR ISSUES. A DEVICE HISTORY RECORD REVIEW FOR THIS INSTRUMENT IS NOT APPLICABLE DUE TO THE AGE OF THE INSTRUMENT. NO PARTS WERE USED AND/OR RETURNED FOR INVESTIGATION. THE ROOT CAUSE IS UNKNOWN. THE ASSIGNABLE CAUSE IS CUSTOMER WORKFLOW ERROR AND/OR REAGENT ISSUE. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS UNCONFIRMED FOR AN INSTRUMENT FAILURE. BD WILL CONTINUE TO MONITOR FOR WORKFLOW ISSUES ON THE BD BACTEC MGIT 960 INSTRUMENTS. CURRENTLY, THE RATE OF COMPLAINTS RELATED TO INSTRUMENT PERFORMANCE/OPERATION IS UNDER STATISTICAL CONTROL. IN JUNE 2020, THERE WERE 19 COMPLAINTS. BASED ON THE PREVIOUS YEAR OF COMPLAINT DATA, 20 COMPLAINTS PER MONTH IS THE AVERAGE (ALERT LEVEL = 26, ACTION LEVEL = 30). TRENDING DID NOT REACH AN ALERT OR ACTION LEVEL. SINCE TRENDING HAVE NOT REACHED, AN ACTION LEVEL AND NO NEW RISKS WERE DETECTED. THUS, A CAPA IS NOT REQUIRED. THE RISK FILES FOR THE BD BACTEC MGIT 960 INSTRUMENT WAS REVIEWED (BALTRM-MGIT320_960-APH, REV 01). THE HAZARD HAVE BEEN IDENTIFIED IN ID 3.5, 6.1 WITH A SEVERITY OF S4. THERE ARE NO OTHER TRENDS, NEW RISKS, OR NEW HAZARDS THERE WERE IDENTIFIED AS A RESULT OF THE COMPLAINT INVESTIGATION. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SYSTEM A POSITIVE TB VIAL LEAKED INTO THE INSTRUMENT. THE CUSTOMER REQUESTED PROTOCOL FOR DECONTAMINATION OF THE INSTRUMENT. THE CUSTOMER INDICATED THAT PPE'S WHERE WORN AND THAT NO PERSON WAS EXPOSED TO THE LAB SPECIMEN AS A RESULT OF THE SPILL. ALL OTHER SAMPLES WERE REMOVED FROM THE INSTRUMENT.
MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SYSTEM A POSITIVE TB VIAL LEAKED INTO THE INSTRUMENT. THE CUSTOMER REQUESTED PROTOCOL FOR DECONTAMINATION OF THE INSTRUMENT. THE CUSTOMER INDICATED THAT PPE'S WHERE WORN AND THAT NO PERSON WAS EXPOSED TO THE LAB SPECIMEN AS A RESULT OF THE SPILL. ALL OTHER SAMPLES WERE REMOVED FROM THE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737958 | BD BACTEC MGIT 960 SYSTEM | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. | 445870 | NA | 00382904458706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |