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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405673
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is hdq us franklin lakes. This site is an oem manufacturing site. Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. The customer's address is unknown. New jersey (nj), usa has been used as a default. Pma/510(k)#: enforcement discretion. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that tray spn whit25g3. 5 l/b-d/e was not working. The following information was provided by the initial reporter: material no. : 405673 ,back no. : unknown (1387545 or 1370473). It was reported that the anesthesia in the trays are not working.
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11586625
MDR Text Key268726714
Report Number2243072-2021-00897
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405673
Device Catalogue Number405673
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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