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

Catalog Number 36154608

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is elitech.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.The reported lot # [00162] was not found for the reported catalog # [36154608].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 the bd sedi-40 instrument had frequent llo errors occurring "randomly" during use, and "strange noises" could be heard during the mixing process.The following information was provided by the initial reporter: "1.Frequent llo error-the blood collection tube is filled over the draw line.This error occurs randomly, it does not matter position in which tube is placed.2.Sometimes customer hear strange noices diring mixing.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 9/1/2020 h.6.Investigation: bd received the unit from the customer for investigation.The unit was evaluated by visual examination and functional testing and the indicated failure mode for llo error and noise with the incident lot was observed.To fix these issues the cal level was adjusted and the plate in the tube cover was replaced.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 that the bd sedi-40 instrument had frequent llo errors occurring "randomly" during use, and "strange noises" could be heard during the mixing process.The following information was provided by the initial reporter: "1.Frequent llo error-the blood collection tube is filled over the draw line.This error occurs randomly, it does not matter position in which tube is placed.2.Sometimes customer hears trange noices diring mixing.".

• 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: 10387515
• MDR Text Key: 205006821
• Report Number: 2243072-2020-01218
• Device Sequence Number: 1
• Product Code: JPH
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 36154608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other