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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT
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BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT Back to Search Results
Catalog Number 361546
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2020
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.Date of event: unknown.The date received by manufacturer has been used.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.(b)(4).
 
Event Description
It was reported the experienced hardware / software malfunction for esr instrument.The following information was provided by the initial reporter: translated to english.The customer stated: "the instrument makes "funny noises" and that it is not running smoothly.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval?: yes.D10/d11: concomitant medical products: returned to manufacturer on: 1/7/2021.H.6.Investigation: instrument sedi 40 00191 was returned to the manufacturer for service with respect to the reported defect ¿ noisy, not running smoothly.The instrument was evaluated by visual examination and functional testing and it was determined that the fan needed replacing.The fan was replaced and the instrument was cleaned.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 the experienced hardware / software malfunction for esr instrument.The following information was provided by the initial reporter: translated to english.The customer stated: "the instrument makes "funny noises" and that it is not running smoothly.".
 
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Brand Name
BD SEDI-40
Type of Device
ESR INSTRUMENT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11165893
MDR Text Key228011772
Report Number2243072-2021-00099
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
PMA/PMN Number
N/A
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 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361546
Device Lot Number00191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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