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

Catalog Number 361546

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Lot #: material 361546 does not need to be handled in batches.Expiration date: na.Manufacturing date : na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd sedi-40 instrument, the device experienced hardware malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: instrument error: issues with the mixing system - is blocking during the run llo error frequently.We dont need an instrument for replacement for the customer.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/10/2022.H.6.Investigation: instrument sedi 40 18-42012 was returned to the manufacturer for service with respect to the reported defect ¿ mixing system issue.The instrument was evaluated by visual examination and functional testing and it was found that the tube cover was unseated.The tube cover was reseated and the plate within the cover was replaced.After repair the instrument passed all further quality checks.

Event Description

It was reported when using the bd sedi-40 instrument, the device experienced hardware malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: instrument error: issues with the mixing system - is blocking during the run llo error frequently we dont need an instrument for replacement for the customer.

• Brand Name: BD SEDI-40 INSTRUMENT
• Type of Device: SEDI INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13160477
• MDR Text Key: 286340645
• Report Number: 2243072-2021-03028
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361546
• Device Lot Number: 1842012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1