MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40 INSTRUMENT; 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 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: 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.

Event Description

It was reported that the bd sedi-40 instrument had a mixing problem.The following information was provided by the initial reporter: instrument do not mix tubes ( mixer is on), there is an info ¿mixing problem.

Event Description

It was reported that the bd sedi-40 instrument had a mixing problem.The following information was provided by the initial reporter: "1) instrument do not mix tubes ( mixer is on), there is an info ¿mixing problem¿".

Manufacturer Narrative

H.6.Investigation summary bd had performed a technical evaluation of the customer's sedi-40 instrument.It was determined that the mixer was not working as a result of the sprocket on the mixer was loose.The instrument repair was performed and upon completion, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.

• Brand Name: BD SEDI-40 INSTRUMENT
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9794612
• MDR Text Key: 185020147
• Report Number: 2243072-2020-00331
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361546
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other