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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT

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BECTON, DICKINSON AND COMPANY BD SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400868
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  malfunction  
Event Description
Failed spinal despite easy placement with csf (cerebrospinal fluid) swirl. Wanted to log lot# in case this happens again.
 
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Brand NameBD SPINAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key12202122
MDR Text Key262663324
Report Number12202122
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400868
Device Lot Number0001398064
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2021
Event Location Hospital
Date Report to Manufacturer07/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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