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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4).
 
Event Description
It was reported that during use with a bd tray spn whit25g3. 5 l/b-d/e plast drape the marcaine is ineffective on an unspecified number of patients. The following information was provided by the initial reporter: it was reported that the marcaine is ineffective on patients. Additionally, on 2020-7-22 the bd sales consultant provided the following additional information: 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 had a customer complain that marcaine from lot #0001350501 is bad. They are currently pulling different marcaine for the defective lots. They state that it is not effective on patients.
 
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Brand NameBD TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10365720
MDR Text Key206939660
Report Number1625685-2020-00068
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
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 Received07/13/2020
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: 08/04/2020 Patient Sequence Number: 1
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