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U.S. Department of Health and Human Services

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

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BECTON DICKINSON BD INSTRUMENT SEDI-40 SEDIMENTION INSTRUMENT Back to Search Results
Catalog Number 361546
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2017
Event Type  malfunction  
Manufacturer Narrative
Medical device lot # unknown. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Results: a sample was returned for evaluation, the instrument was tested and was found to be incorrectly calibrated ¿ this was corrected and a new fan installed as the existing one was noisy. Conclusion: root cause is indeterminate.
 
Event Description
It was reported that bd instrument sedi-40 had llo messages and inadequate filling upon use. No medical intervention or injury reported.
 
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Brand NameBD INSTRUMENT SEDI-40
Type of DeviceSEDIMENTION 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
8015652845
MDR Report Key7081305
MDR Text Key94409365
Report Number2243072-2017-00296
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361546
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
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

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
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