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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SEDI-20 INSTRUMENT ESR INSTRUMENT

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BECTON DICKINSON BD¿ SEDI-20 INSTRUMENT ESR INSTRUMENT Back to Search Results
Catalog Number 361545
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2018
Event Type  malfunction  
Manufacturer Narrative
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 in sections and the (b)(4) fda registration number has been used for the manufacture report number. The date received by manufacturer has been used for this field. Batch number sn16-40001 was reported, and not found for the catalog number reported. (b)(6). 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 with the use of the bd¿ sedi-20 instrument there was an issue with screen not working. There was no report of injury or medical intervention.
 
Event Description
It was reported with the use of the bd sedi-20 instrument there was an issue with screen not working. There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: dhr could not be performed because the batch number does not exist in the database. Bd had performed a technical evaluation of the customer's sedi-20 instrument. It was determined that a loose connector was causing the screen issues and the connector was fixed. Upon completion of the repair service, the instrument was verified to be operating within the correct parameters. Based on evaluation of the customer's instrument, a loose connector was observed to be causing the screen issues. The root cause was attributed to a loose connector. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
 
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Brand NameBD¿ SEDI-20 INSTRUMENT
Type of DeviceESR INSTRUMENT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7890625
MDR Text Key120981466
Report Number2243072-2018-01362
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 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361545
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/19/2018 Patient Sequence Number: 1
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