MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT

Catalog Number 361546

Device Problem Break (1069)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Device manufacture date: unknown.

Event Description

It was reported when using the bd sedi-40 there was hardware / software malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: "during operation, there is a risk of breaking the cover plate, which can cause the vacutainers to fall out of the slots, thus stopping the work process or giving wrong results.".

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-14.H.6.Investigation summary: instrument sedi 40 17-42011 was returned to the manufacturer for service with respect to the reported defect ¿ broken cover plater.The instrument was evaluated by visual examination and functional testing and it was found that the cover plate was broken.The cover plate was replaced.After repair the instrument passed all further quality checks.

Event Description

It was reported when using the bd sedi-40 there was hardware / software malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: "during operation, there is a risk of breaking the cover plate, which can cause the vacutainers to fall out of the slots, thus stopping the work process or giving wrong results.".

• Brand Name: BD SEDI-40
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15201125
• MDR Text Key: 304886819
• Report Number: 2243072-2022-01306
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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