MAUDE Adverse Event Report: BECTON DICKINSON BD SEDISYSTEM¿ ESR INSTRUMENT

Catalog Number 366076

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.(b)(6).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 with the use of the bd sedisystem¿ esr instrument there was an issue with hardware/software malfunction.There was no report of injury or further medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.A service work order indicates that the instrument was evaluated, repaired, restarted and a performance check showed no issues.Based on the service work order conducted, no additional issues were observed.The root cause was determined to be a loose printer holder cartridge.The component was replaced and the device is functioning correctly.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported with the use of the bd sedisystem esr instrument there was an issue with hardware/software malfunction.There was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd sedisystem esr instrument there was an issue with hardware/software malfunction.There was no report of injury or further medical intervention.

Manufacturer Narrative

The oem manufacturer has been updated.(b)(4).

Event Description

It was reported with the use of the bd sedisystem¿ esr instrument there was an issue with hardware/software malfunction.There was no report of injury or further medical intervention.

Manufacturer Narrative

The bd sedi-15 instrument (catalog no.366076) was discontinued in january 2010 and is no longer distributed by bd.Additional information was received on 10/30/2018 from the bd technical support team who conducts a repair service on the device referenced in this report.It was determined that this device is not a bd sedi-15 catalog no.366076, but rather a non-bd printer.A processing error had occurred where the printer was logged into the service request system as the ¿bd sedi-15 catalog no.366076¿.As a result, the current complaint referencing the bd sedi-15 catalog no.366076 will be cancelled in our complaint system as it is not associated with our bd products.We have also taken necessary actions to prevent this processing error from recurring in the future.

Manufacturer Narrative

This supplemental is being filed to correct follow up number on mfg report# 2243072-2018-01030 follow up 4, which should have been follow up 3.

Event Description

It was reported with the use of the bd sedisystem¿ esr instrument there was an issue with hardware/software malfunction.There was no report of injury or further medical intervention.

• Brand Name: BD SEDISYSTEM¿ ESR INSTRUMENT
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7749213
• MDR Text Key: 116226496
• Report Number: 2243072-2018-01030
• Device Sequence Number: 1
• Product Code: JPH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 366076
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 07/18/2018; 08/02/2023
• Supplement Dates FDA Received: 09/27/2018; 10/31/2018; 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other