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 Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported before use the bd sedi-40 had hardware / software malfunction for esr instrument.The following information was provided by the initial reporter: ¿mixer does not work ( it is "on" in a setup).¿.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 2020-09-07 h.6.Investigation summary bd received the faulty instrument from the customer for investigation.The instrument was evaluated by visual examination and functional testing and the sprocket that drives the tube holder was found to be loose.The sprocket was re-seated and the instrument was confirmed to meet specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.

Event Description

It was reported before use the bd sedi-40 had hardware / software malfunction for esr instrument.The following information was provided by the initial reporter: ¿mixer does not work ( it is "on" in a setup)¿.

• 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: 10586561
• MDR Text Key: 209851927
• Report Number: 2243072-2020-01501
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361546
• Device Lot Number: 15-42008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other