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 09/02/2019

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: 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 during use of the bd sedi-40 there is a noise when using the instrument, but it works.The following information was provided by the initial reporter: its noise when using the sedi 40 instrument, but it works.

Manufacturer Narrative

H.6.Investigation: bd received service report for the investigation.The equipment was tested/evaluated and the customer's indicated failure mode for "noisy" with the incident lot was not observed as was found to be functioning correctly.Based on the investigation, a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that during use of the bd sedi-40 there is a noise when using the instrument, but t works.The following information was provided by the initial reporter: its noise when using the sedi 40 instrument, but it works.

• 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: 9082449
• MDR Text Key: 174741079
• Report Number: 2243072-2019-02054
• 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: 10/02/2019

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: UNKNOWN
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other