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

Model Number 445870

Device Problem Unintended Electrical Shock (4018)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that a user suffered an electric shock when plugging a mgit instrument into a wall socket.The user further clarified that there was no injury or burn as a result of the shock, and no additional malfunction was reported.The following information was provided by the initial reporter: a staff member removed one plug (the main plug for mgit 1) to put back into the wall socket, as they were about to re-plug into the wall socket they got an electric shock.After further confirmation there was no injury.

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Initial reporter phone: (b)(6).

Event Description

It was reported that a user suffered an electric shock when plugging a mgit instrument into a wall socket.The user further clarified that there was no injury or burn as a result of the shock, and no additional malfunction was reported.The following information was provided by the initial reporter: a staff member removed one plug (the main plug for mgit 1) to put back into the wall socket, as they were about to re-plug into the wall socket they got an electric shock.After further confirmation there was no injury.

Manufacturer Narrative

"this complaint alleges a failure on a mgit 960 instrument p/n 445870, s/n (b)(6).It was reported that during a facility generator test a customer unplugged a mgit instrument and while plugging the instrument back in the customer received a shock.It was also reported that the facility power may surge during the generator testing.The customer who received the shock did not need to seek medical treatment and did not have any burns or injuries as a result of the shock.A field service engineer (fse) was dispatched to troubleshoot the instrument.The fse checked the power socket, ups, power cables and ground equipment and found no burn marks or scorching.The instrument was functioning as expected and no issues were noted.The fse noted that the lab tech was wearing a synthetic lab coat which could potentially contribute to a static discharge.The bd mgit 960 instrument has been designed and manufactured in such a way as to reduce, as far as possible, the risks of electrical shock, explosion, fire, spread of fire outside the instrument, elimination or reduction of the sources of ignition within the instrument, and containment of a fire within the instrument, should it occur.Balttf0012 technical file - bd mgit 960, documents the four (4) applicable standards the instrument conforms to, including the following: en61010-1:2001, safety requirements for electrical equipment for measurement, control, and laboratory use iec 61010-1:2001, safety requirements for electrical equipment for measurement, control, and laboratory use the customer ups that was plugged into the wall was returned to quality for investigation.Manufacturing engineering inspected the ups.The ups was connected and ran as expected.The measurement between the instrument ground and ups ground was as expected at 0.3 ohms, 2.4 mvac.The ups was run for approximately a week with no problems.Review of device history record is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no additional work orders were observed for the complaint failure mode reported.The root cause is unknown at this time.This is an unconfirmed failure of a bd product.Complaint history for safety was reviewed for the month of december.The upper control limit was not breached, and trends were not identified associated with this defect.No new trends, risks, or hazards were identified as a result of this complaint.The issue in this complaint does not require the initiation of a corrective and preventative action (capa).This complaint will be included in the periodic trend review.

• 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: 16052189
• MDR Text Key: 306897298
• Report Number: 1119779-2022-01546
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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: 12/05/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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