MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BACTEC¿ MGIT¿ 960 SYSTEM; MYCOBACTERIA TESTING

Model Number 445870

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint was created for workflow issues on the bactec mgit 960 instrument (p/n 445870, (b)(4)).The customer reported during the standard loading of ast tubes, one of the samples were loaded upside down.The cap on that sample tube was loose.Hence, the sample spilled into the sample drawer.Ast tubes are positive for tb.The instrument was turned off.Bd service provided instructions to the customer on how to decontaminate the instrument and samples.The customer followed their own protocols for spills and the spill was cleaned and the instrument was decontaminated.There was no injury or exposure to the customer as the customer wore personal protective equipment.The root cause of the issue was a workflow error causing a loose cap on the ast sample tube.A review of the service history for serial number (b)(4) showed there were no further complaints regarding this issue.A device history record review is not needed due to the age of the instrument.Decontamination instructions are provided in the bactec mgit user's manual ma0117, section 6.2.3.5.The manual states, "in the event of tube leakage or breakage: close the instrument drawers; turn off the instrument; vacate the area immediately; consult your facility/cdc guidelines.An inoculated leaking or broken tube may produce an aerosol of mycobacteria; appropriate handling should be observed." based on the information provided, the complaint is unconfirmed for an instrument failure.Bd quality will continue to monitor for workflow issues on the bactec mgit 960 instruments.Investigation conclusion: the complaint was unconfirmed for an instrument failure.Currently, the rate of complaints related to instrument performance / operation are under statistical control.In may 2020, there were 10 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 ((b)(4)).The hazard have been identified in id 3.5 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.Root cause description: the root cause of the issue was a workflow error causing a loose cap on the ast sample tube.Rationale: since trending have not reached, an action level and no new risks were detected.Thus, a capa is not required.

Event Description

It was reported that while loading an ast tube on the bd bactec¿ mgit¿ 960 system the tube cap was not fully on and the sample spilled in the instrument drawer.The tube reportedly contained a positive mycobacterium tuberculosis culture.The instrument underwent required decontamination.Samples were removed and transferred to a spare 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.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SYSTEM
• Type of Device: MYCOBACTERIA TESTING
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10181847
• MDR Text Key: 206177979
• Report Number: 1119779-2020-00165
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 445870
• Device Catalogue Number: 445870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other