MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256066

Device Problem Fire (1245)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported that bd veritor plus analyzer caught on fire.The following information was provided by the initial reporter: it was reported by the customer as their analyzer caught on fire.Overview of hospital/facility and how instrument is used: employee health clinic - clinic and employee health services.Covid flu ab combo (veritor), ua testing, strep.Instrument in back office with poc testing machines, non mobile.Counterspace with veritor, clinitek, strep poc machine - set up next to sink and computer, everything stays plugged in entire time.Labels attached to adapter that were provided with recall device is plugged in all the time and does not leave bench.Power supplies for other poc devices: unknown if the same as veritor.Nps do not generally use machine but mas and specialists perform testing.20-40 tests/week on average for veritor.Multiple other veritors being used in organization.Incident occurred around (b)(6) 2022 11am pst employee walked by and device made popping noise and caught on fire.Fire extinguisher used to extinguish fire.Instrument used last before fire qc tests run day of, and was used monday morning for patient testing (b)(6) 2022.Some lengths of time where it has shut off and will not turn back on - occasionally taken to different location to plug in and will start recharging again (instrument and plug taken to different location) see (b)(4).Has hard power on (hold button down for 5 sec) been done previously? unknown.Still have not gotten replacement from recall but only temporary replacement with cord from organization.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were added.Remedial action #: (b)(4).

Event Description

It was reported that a bd veritor instrument caught on fire.The analyzer was plugged in, but not in use at the time of the incident.The fire was extinguished and no injuries were reported.The following information was provided by the initial reporter: "customer reported that their analyzer caught on fire.Hazard, injury or erroneous results? yes hazard, injury or erroneous results details the analyzer caught on fire and exploded.No one was injured or no one received any medical treatment.Customer used the fire extinguisher to put out the fire.".

Manufacturer Narrative

H.6 investigation summary the complaint alleges the bd veritor plus analyzer caught on fire (catalog number 256066,serial number (b)(6)).The veritor plus analyzer was returned for investigation.The root cause of the failure was due to with an overheated li-ion battery cell.Pictures attached shows damage was consistent with thermal runaway of the rechargeable lithium ion (li-ion) battery within the unit.This complaint is a confirmed failure of the bd product.Internal corrective action taken to address this failure mode.Dhr for veritor plus analyzer,serial number (b)(6) was reviewed and nonconformances related to this failure mode were not revealed in manufacturing during final testing.The device was released conforming.Bd quality will continue to closely monitor for trends associated with this complaint h3 other text : see h.10.

Event Description

It was reported that a bd veritor instrument caught on fire.The analyzer was plugged in, but not in use at the time of the incident.The fire was extinguished and no injuries were reported.The following information was provided by the initial reporter: "customer reported that their analyzer caught on fire.Hazard, injury or erroneous results? yes hazard, injury or erroneous results details the analyzer caught on fire and exploded.No one was injured or no one received any medical treatment.Customer used the fire extinguisher to put out the fire.".

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: 15884026
• MDR Text Key: 304501129
• Report Number: 1119779-2022-01436
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: IDS-21-4213-FA
• Patient Sequence Number: 1