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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE ANESTHESIA TRAY

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE ANESTHESIA TRAY Back to Search Results
Model Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Awareness during Anaesthesia (1707); Headache (1880)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field.
 
Event Description
It was reported that tray spn whit25g3. 5 l/b-d/e plast drape had ineffective anesthesia. The following information was provided by the initial reporter: "it was reported that patient had to receive 2 spinals as the first spinal was with the bad marcaine, resulting with patient having a spinal headache. Pr 684960 related complaint. Issue: i know of 4 times in a one week period. After that we started not using the marcaine in the kits. I don¿t know the exact week, but i am thinking the first full week in july. We had one adverse event from a patient with a spinal headache. She had to have 2 spinals as the first one was the bad marcaine. I know of 4 times in a one week period. After that we started not using the marcaine in the kits. I don¿t know the exact week, but i am thinking the first full week in july. We had one adverse event from a patient with a spinal headache. She had to have 2 spinals as the first one was the bad marcaine. ".
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of DeviceANESTHESIA TRAY
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10411615
MDR Text Key204218959
Report Number1625685-2020-00074
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 foreign,other,user facility
Type of Report Initial
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Model Number405671
Device Catalogue Number405671
Device Lot Number0001350501
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2020
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: 08/14/2020 Patient Sequence Number: 1
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