MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VERITOR PLUS ANALYZER; COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

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

In late morning, a bd veritor plus analyzer used in the hospital's employee health building and stored in a room at the west end of the building caught on fire.Staff were able to put out the fire with a fire extinguisher without injury or structural damage to the building/office.The employee health office was closed for two days during cleanup as a result of the fire.Manufacturer response for colorimeter, photometer, spectrophotometer for clinical use, bd veritor; plus analyzer (per site reporter).They fire event was reported to bd on the day it occurred.In an email, bd apologized for the incident and requested additional information about the fire incident, including photos of the affected device and a request that the defective unit together with the burnt charger and cord be returned to their bd facility for quality investigation.Emails between bd and facility stating, "you can continue to use the bd veritor analyzers you have until you receive replacement.However, we recommend that you follow the safety guidelines laid out in the product advisory." a replacement for the bd veritor analyzer that caught on fire had not yet been received.An email from bd stated that bd was able to get replacement analyzers ordered and that they would be shipping out soon.As of the date of this report, the hospital still has not received the replacement analyzers.

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 15904421
• MDR Text Key: 304694478
• Report Number: 15904421
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661(17)2101241J0AA0(10)2056066
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2022
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1