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

Catalog Number 361546

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

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

Event Date 11/14/2018

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 and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: n/a.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: n/a.

Event Description

It was reported that during use of the bd¿ sedi-40 an error message of low level too low even though the tube are filled to proper level.This has been happening for the last four months.

Event Description

It was reported that during use of the bd¿ sedi-40 an error message of llow level too low even though the tube are filled to proper level.This has been happening for the last four months.

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had performed a technical evaluation of the customer's sedi-40 instrument and the level too low error was observed.It was determined that the malfunction was attributed to a broken plexiglas plate in the tube lid.Upon completion of the instrument evaluation and subsequent repair, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.Investigation conclusion: based on evaluation of the customer's instrument, the level too low error was observed.Root cause description: the root cause was determined to be a broken plexiglas plate in the tube lid.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.

• Brand Name: BD¿ SEDI-40
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8391093
• MDR Text Key: 139202862
• Report Number: 2243072-2019-00395
• Device Sequence Number: 1
• Product Code: JPH
• 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: 04/10/2019

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: 361546
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other