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

Catalog Number 366076

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 that the bd¿ sedisystem esr instrument left "erroneous boxes".There was no report of exposure, injury, or 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.

Event Description

It was reported that the bd¿ sedisystem esr instrument left "erroneous boxes".There was no report of exposure, injury, or 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
• MDR Report Key: 8019461
• MDR Text Key: 125614218
• Report Number: 2243072-2018-01533
• Device Sequence Number: 1
• Product Code: JKA
• 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
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other