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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 Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. 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.
 
Event Description
It was reported that bd sedi-40 had a hardware malfunction. The following information was provided by the initial reporter: "the exhaust fan is making rattle noises. Mixer cover is broken. Please check instrument sensor reading because the laboratory find out significant differences between the results compared with another sedi 40 instruments in the laboratory. Customer made test comparison with a hospital nurse blood sample and esr was increased. Also during a batch readings some samples were not red but produced llo error although tubes were filled correctly. ".
 
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Brand NameBD SEDI-40
Type of DeviceESR 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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11703218
MDR Text Key253171128
Report Number2243072-2021-01214
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,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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