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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2017
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Medical device expiration date: unknown. Device manufacture date: unknown. Results: bd received 1 instrument returned from the customer facility for investigation. The returned unit was returned to the manufacturer for service, and it was observed that the tube cover was broken. The cover was replaced by the manufacturer and returned to the customer. Conclusion: based on the investigation, a root cause could not be determined within the scope of this evaluation. Bd was able to duplicate or confirm the customer¿s indicated failure mode.
 
Event Description
It was reported that the bd instrument sedi-40 tube cover was broken. No serious injury or medical intervention 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 Key7100309
MDR Text Key94987191
Report Number2243072-2017-00367
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodeDA
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
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 Manufacturer07/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
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: 12/08/2017 Patient Sequence Number: 1
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