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 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is elitech.This site is an oem manufacturing site.Medical device expiration date: unknown.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 that the roller on the bd¿ sedisystem esr instrument stopped.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the roller on the bd¿ sedisystem esr instrument stopped.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Oem manufacturer: 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 and the (b)(4) fda registration number has been used for the manufacture report number.

Manufacturer Narrative

Investigation summary: a service work order indicates that the instrument was evaluated, repaired, restarted and a performance check showed no issues.Investigation conclusion: based on the service work order conducted, no additional issues were observed.Root cause description: the root cause was determined to be a printer driver (software) issue.The issue was corrected and no further errors reported.Rationale: 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.Correction: due to an it issue beginning on 7/3/2018, 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: yes.

Event Description

It was reported that the roller on the bd¿ sedisystem esr instrument stopped.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: 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.

Event Description

It was reported that the roller on the bd¿ sedisystem esr instrument stopped.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD¿ SEDISYSTEM ESR INSTRUMENT
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7751891
• MDR Text Key: 116542772
• Report Number: 2243072-2018-01021
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• 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: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 07/16/2018; 07/16/2018
• Supplement Dates FDA Received: 09/27/2018; 10/31/2018; 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other