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U.S. Department of Health and Human Services

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

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BECTON DICKINSON BD SEDI-40 INSTRUMENT SEDI INSTRUMENT Back to Search Results
Catalog Number 361546
Device Problem Incorrect, Inadequate or Imprecise Resultor 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.
 
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Brand NameBD SEDI-40 INSTRUMENT
Type of DeviceSEDI 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 Key13160477
MDR Text Key286340645
Report Number2243072-2021-03028
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number361546
Device Lot Number1842012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
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

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