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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAY ANESTHESIA KIT
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BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAY ANESTHESIA KIT Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Unknown manufacturer: (b)(4). 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 tray failed. The following information was provided by the initial reporter: material no. Unknown, batch no. Unknown. It is reported customer experienced 2 occasions of failed spinals. Verbiage received, - "after having no problems with the bupi from the kit. I've had 2 failed spinals in a row. One was a cerclage and one is a section. The h2 numbers are h20502733 and h20501524. Both vials of bupi were from the same batch #960803a, exp. 12/21. I'll be using the bupi from the pyxis now. ".
 
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Brand NameUNSPECIFIED BD¿ SPINAL TRAY
Type of DeviceANESTHESIA KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10939290
MDR Text Key221293344
Report Number2243072-2020-01984
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 other,user facility
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
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 Received05/04/2021
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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