MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SEDI-20 INSTRUMENT; ESR INSTRUMENT

Catalog Number 361545

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

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

Event Date 08/30/2018

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.The date received by manufacturer has been used for this field.Batch number sn16-40001 was reported, and not found for the catalog number reported.(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¿ sedi-20 instrument there was an issue with screen not working.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd sedi-20 instrument there was an issue with screen not working.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: dhr could not be performed because the batch number does not exist in the database.Bd had performed a technical evaluation of the customer's sedi-20 instrument.It was determined that a loose connector was causing the screen issues and the connector was fixed.Upon completion of the repair service, the instrument was verified to be operating within the correct parameters.Based on evaluation of the customer's instrument, a loose connector was observed to be causing the screen issues.The root cause was attributed to a loose connector.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.

• Brand Name: BD¿ SEDI-20 INSTRUMENT
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7890625
• MDR Text Key: 120981466
• Report Number: 2243072-2018-01362
• 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
• Report Date: 10/22/2018

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: 361545
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other