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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAYS ANESTHESIA KIT

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BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAYS ANESTHESIA KIT Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Awareness during Anaesthesia (1707); Insufficient Information (4580)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: 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. 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. 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. (b)(4).
 
Event Description
It was reported that unspecified bd¿ spinal trays are not setting up properly. The following information was provided by the initial reporter: material no. : unknown, batch no. : unknown. It was reported that the spinal trays are not setting up properly. Per response email: yes we have several kits now that have not worked on patients i sent a couple of the front part of the kits in quite a while never heard back on them and when i complained about it again they said you never received anything. I have complained a couple times about this. Per email: we have had several spinal kits now since i complained before that its not setting up as a spinal and they end up putting the patient to sleep. So can you tell me what is going on with the trays because i sent like 3 of them in with lot numbers and everything and i never heard back from you.
 
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Brand NameUNSPECIFIED BD¿ SPINAL TRAYS
Type of DeviceANESTHESIA KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10891686
MDR Text Key217958990
Report Number2243072-2020-01918
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
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

Patient Treatment Data
Date Received: 11/24/2020 Patient Sequence Number: 1
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