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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
Catalog Number 405637
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 05/18/2020
Event Type  Injury  
Event Description
(b)(6) year old female admitted (b)(6) 2020 for pre-eclampsia and gestational diabetes management. On (b)(6) 2020 due to severe pre-eclampsia goes to operating room for c-section. During spinal epidural tip of needle is noticed to be broken upon removal. Needle send to pathology. The needle was removed (b)(6) by neurologist in the operating room under fluro. Neurologist signed off (b)(6). The patient discharged (b)(6). She was up ambulating with minimal pain per the md note. Fda safety report id #: (b)(4).
 
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Brand NameBD SPINAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
franklin lakes NJ 07417
MDR Report Key10100832
MDR Text Key193313185
Report NumberMW5094740
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number405637
Device Lot Number0001330369
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/28/2020 Patient Sequence Number: 1
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