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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ TRAY SPN SPT24G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD¿ TRAY SPN SPT24G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405637
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Underdose (2542)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001315906. Medical device expiration date: unknown. Device manufacture date: 2019-08-14. Medical device lot #: 0001318731. Medical device expiration date: 2021-05-31. Device manufacture date: 2019-09-05. Initial reporter facility: the user facility address is not available, the corporate headquarters information was used instead. Pma/510(k)#: enforcement discretion. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that the bd¿ tray spn spt24g3. 5 l/b-d/e has been found with ineffective anesthesia during use. The following has been provided by the initial reporter: material no. : 405637, batch no. : 0001315906 & 000138731. It was reported the patients are not getting good motor block and minimal sensory block resulting in them having to revert to general anesthesia. Verbatim: the 2 above lot #'s were used (b)(6) 2019. Patients are not getting good motor block & minimal sensory block. Anesthesia is having to revert to general on these and other cases. There were a couple of cases over the weekend & a couple last week.
 
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Brand NameBD¿ TRAY SPN SPT24G3.5 L/B-D/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key9534180
MDR Text Key195559969
Report Number1625685-2019-00144
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number405637
Device Catalogue Number405637
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/31/2019 Patient Sequence Number: 1
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