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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-20 ESR INSTRUMENT

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BECTON DICKINSON BD SEDI-20 ESR INSTRUMENT Back to Search Results
Catalog Number 361545
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: 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. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: instrument sedi 20 15-40002 was returned to the manufacturer for service with respect to the reported defect ¿ broken power socket. The instrument was evaluated by visual examination and functional testing and the power socket entry was broken. A new power socket was soldered on and the instrument is working according to specification.
 
Event Description
It was reported when using the bd sedi-20 there was a hardware/software malfunction for esr instrument. The following information was provided by the initial reporter. The customer stated: a "part is broken. ".
 
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Brand NameBD SEDI-20
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12468868
MDR Text Key272457912
Report Number2243072-2021-02310
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? No
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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