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 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 the bd veritor¿ plus analyzer caught on fire when used with the original charger and a micro usb cord from a zebra printer.There was no report of adverse user impact.The following information was provided by the initial reporter: "red zone cctv shows smoke & fire coming out from analyzer.Security guard when to put out & inform." "he don't know how the fire occurred as he was informed by.Cleaning company, this two items was in the red zone." "customer was using original charger.They were using a micro usb cord from a zebra printer.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-14.H6: investigation summary the complaint was created for burnt veritor analyzer and burnt infoscan issues on the bd veritor plus analyzer (p/n 256066, s/n (b)(6)).The device history record for bd veritor plus analyzer, sn (b)(6), was examined and showed no discrepancies related to this issue that can be correlated to this complaint.The reader passed all the tests including the final assembly process, oqa, source inspection, functionality, final packing test and manual inspection.The burnt analyzer was returned for investigation.The instrument shows very extensive heat damage.The instrument serial number is not readable because of the damaged label.The infoscan serial number is (b)(6).The internal and external damage to the plastic parts, main circuit board, and battery cell are consistent with thermal runaway of the li-ion cell.A photograph taken at the time of the incident shows that a different power supply had been used.The power supply returned with the unit is a bd veritor power supply.A subsequent photograph confirmed that the power supply with 12 v output was incompatible with the veritor analyzer.The maximum allowed voltage for the li-ion cell is 4.2 v and higher voltages can lead to cell failure.The root cause is determined to be an overvoltage event.Corrective and preventive action(s) have been implemented to address this issue and determine root cause(s).Capa 1937834 have been created to address this issue.Based on this evidence the complaint is confirmed.Bd quality will continue to monitor for trends related to the veritor system and power issues.

Event Description

It was reported that the bd veritor¿ plus analyzer caught on fire when used with the original charger and a micro usb cord from a zebra printer.There was no report of adverse user impact.The following information was provided by the initial reporter: "red zone cctv shows smoke & fire coming out from analyzer.Security guard when to put out & inform." "he don¿t know how the fire occurred as he was informed by.Cleaning company, this two items was in the red zone"."customer was using original charger.They were using a micro usb cord from a zebra printer.".

• 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: 13524558
• MDR Text Key: 288279203
• Report Number: 1119779-2022-00237
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• 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