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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SEDI-40 INSTR. DEFECTIVE ESR INSTRUMENT

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BECTON DICKINSON SEDI-40 INSTR. DEFECTIVE ESR INSTRUMENT Back to Search Results
Catalog Number 36154608
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the sedi-40 instr. Defective experienced a failure to contain blood/medication. The following information was provided by the initial reporter: broken tube cover.
 
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Brand NameSEDI-40 INSTR. DEFECTIVE
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
8015652341
MDR Report Key8586762
MDR Text Key148423610
Report Number2243072-2019-00866
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodeHR
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number36154608
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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: 05/07/2019 Patient Sequence Number: 1
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