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

Catalog Number 445870

Device Problem Fire (1245)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system that the mgit caught fire.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details the ups caught fire.Fire did no harm to lab staff, nor to any objects.It didn't affect the mgit either.In the laboratory they have had a power outage, and the ups has caught fire.No person or instrument has been damaged.

Manufacturer Narrative

H.6.Investigation summary: catalog # 445870, s/n (b)(6): the customer reported the laboratory had a power outage and the ups caught fire.No person or instrument was reported as damaged.An fse went on site and uninstalled the failing ups.The fse made no mention of evidence of a fire and provided photos of the removed ups confirming that there was no evidence of the ups catching file.The photos have been attached to (b)(4).Since a burning smell was noted the following is an applicable statement about the instrument: 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 and iec 61010-1:2001, safety requirements for electrical equipment for measurement, control, and laboratory use.The root cause of the complaint was that the ups failed during a power outage at the laboratory.This complaint is not confirmed because it was not an instrument malfunction and the ups is considered a consumable accessory that requires periodic replacement.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no recent additional work orders were observed for the complaint failure mode reported.No samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.Bd quality will continue to closely monitor for trends associated with results related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system that the mgit caught fire.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details the ups caught fire.Fire did no harm to lab staff, nor to any objects.It didn't affect the mgit either.In the laboratory they have had a power outage, and the ups has caught fire.No person or instrument has been damaged.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17909806
• MDR Text Key: 325335469
• Report Number: 1119779-2023-01076
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 10/26/2023

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 Catalogue Number: 445870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/07/2023
• 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