MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING

Model Number 445870

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a complaint of "cracked vial" was received against bactec mgit 960 instrument material number: 445870, serial number: (b)(4).A bd remote assistance associate communicated with the customer and confirmed that the vial tube was found to be cracked due to this, customer could not be able to find out the liquid in the station well or instrument and confirmed that the customer was decontaminated the station well with the microbial decontamination solution, thus the issue was resolved.Instrument was working without error and the customer started using the instrument for regular use.This is an unconfirmed complaint, and the root cause was undetermined.Dhr review for the instrument mg4489, is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Complaints for "instrument performance / operation" are under statistical control for the month of may 2022.The upper control limit was not breached.Quality will continue to monitor the "instrument performance / operation".No new trends have been identified.Review of risk management documentation indicates that the potential risk of the reported failure mode was assessed as severity s1 (user inconvenience) via document baltrm-mgit320_960-aph revision 05 id 8.12.

Event Description

It has been reported that the bd bactec¿ mgit¿ 960 system has been found leaking patient sample.The following has been provided by the initial reporter: it was reported by the customer that they discovered a vial that had a hairline crack in it, the vial had no liquid/patient sample in it.1.Was the leak contained within the instrument? yes.2.Was the leak in a customer-accessible location? yes; the customer has examined and sees no evidence of fluid in the station well or instrument.3.What was the fluid that leaked (patient or qc)? patient.4.Was the customer exposed to blood or bodily fluids? no.5.Was there any physical harm to the customer as a result of the leak? no, the customer is wearing an n95 mask and gloves.Customer problem: the customer discovered a vial that had a hairline crack in it, the vial had no liquid/patient sample in it.Steps were taken with customer/troubleshooting: a vial tube was found cracked today and all the liquid had leaked out.The customer could not find any signs of liquid in the station wells or instrument.All the liquid had evaporated and the instrument has been operating normally.I confirmed with the customer that they would be decontaminating the station well.They will be using a microbial decontamination solution to clean the well.We had a vial that had no liquid in it.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SYSTEM
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14932468
• MDR Text Key: 303435456
• Report Number: 1119779-2022-00958
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/25/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1