MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Model Number 441916

Device Problem Fire (1245)

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

Event Date 10/08/2021

Event Type  malfunction  

Event Description

It was reported that while using the bd instrument max clinical an explosion was observed by the laboratory personnel.There was no impact.Assays used: unspecified.The following information was provided by the initial reporter: "it felt like a small explosion, everything went off, and now there is a smell of burning.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k130470.

Manufacturer Narrative

H6: investigation summary a power failure/ups complaint was reported against the bd max instrument catalog number 441916, serial number (b)(4).The customer reported hearing an explosive sound coming from the vicinity of the instrument.They noted that all power was lost and that they noticed a burning smell.Field service was dispatched.Field service disassembled the instrument to determine if the instrument was burnt.No portion of the bd instrument was burnt, but the smell was determined to be coming from the ups.The ups was replaced and instrument was returned to the customer functional.No parts are being returned to bd for investigation.The complaint is unconfirmed.The root cause is due to the ups functioning as its intended design by tripping the breaker due to a facility electrical surge.Investigation consisted of a review of the instrument installation, service history, and related complaint data.Bd will continually monitor for trends related to this complaint.H3 other text : see h10.

Event Description

It was reported that while using the bd instrument max clinical an explosion was observed by the laboratory personnel.There was no impact.Assays used: unspecified the following information was provided by the initial reporter: " it felt like a small explosion, everything went off, and now there is a smell of burning".

• Brand Name: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
• Type of Device: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12760818
• MDR Text Key: 280439845
• Report Number: 1119779-2021-01771
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K111860
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441916
• Device Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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