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 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date: unknown.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 while using bd veritor plus analyzer a fire occurred.There was no report of patient impact.The following information was provided by the initial reporter: no people were affected on this incident.It was reported that analyzer caught on fire when was connected with a different a/c cord.

Manufacturer Narrative

Investigation: the complaint was created for power issue on the bd veritor plus analyzer.The customer reports of analyzer catching fire.The serial number of the analyzer was not provided thus no dhr review was performed.The alleged bd veritor plus analyzer was not returned for investigation and the serial number was not provided.Based on the information and pictures provided it is clear that the customer was using an unauthorized power supply or power adopter that can lead to component failure.Since the analyzer was not returned no root cause analysis can be performed.This complaint is unconfirmed.Bd quality will continue to monitor for trends related to the veritor system and power issues.

Event Description

It was reported while using bd veritor plus analyzer a fire occurred.There was no report of patient impact.The following information was provided by the initial reporter: no people were afected on this incident.It was reported that analyzer caught on fire when was connected with a different a/c cord.

• 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: 13808680
• MDR Text Key: 287404119
• Report Number: 1119779-2022-00445
• 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
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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