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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 BLUE DRAPE ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405672
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the tray spn whit25g3. 5 l/b-d/e blue drape was ineffective, and the treatment failed to work. The following information was provided by the initial reporter: there were several consecutive failed spinal anesthetics on ob. Consistent factor has been using the spinal bupivacaine (0. 75%) from the kits.
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12475278
MDR Text Key271513781
Report Number2243072-2021-02320
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number405672
Device Catalogue Number405672
Device Lot Number0001387936
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2020
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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