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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-20; ESR INSTRUMENT
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BECTON DICKINSON BD SEDI-20; ESR INSTRUMENT Back to Search Results
Catalog Number 361545
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
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.Device manufacture date: unknown.
 
Event Description
It was reported that bd sedi-20 had a hardware malfunction.The following information was provided by the initial reporter: "the screen is very dark and data are not visble ( probably there is an issue with a light bulb.".
 
Event Description
It was reported that bd sedi-20 had a hardware malfunction.The following information was provided by the initial reporter: "the screen is very dark and data are not visble ( probably there is an issue with a light bulb.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/20/2021.H.6.Investigation: instrument sedi 20 17-40006 was returned to the manufacturer for service with respect to the reported defect ¿ dark screen.The instrument was evaluated by visual examination and functional testing and the backlight was found to not be working.The display was replaced and no additional defects were found.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.
 
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Brand Name
BD SEDI-20
Type of Device
ESR INSTRUMENT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11832425
MDR Text Key256725701
Report Number2243072-2021-01490
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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