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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE17G3.5 SWC X3796 ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY EPID CONT WE17G3.5 SWC X3796 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 406151
Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the catheter from the tray epid cont we17g3. 5 swc x3796 disconnected from the stingray during an epidural on an icu patient, and the nurses stated the catheter was not one they had seen before. Additionally, it was reported that the anesthesiologist had to be called in the middle of the night to walk the staff through the situation. The following information was provided by the initial reporter: the other night, the icu had a patient with an epidural catheter that became disconnected. The nurses reported this was not an epidural catheter they had ever seen before. They called anesthesia in the middle of the night and the anesthesiologist talked them through what to do for a disconnect of this type of catheter.
 
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Brand NameTRAY EPID CONT WE17G3.5 SWC X3796
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8728223
MDR Text Key149079475
Report Number1625685-2019-00054
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 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number406151
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
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: 06/24/2019 Patient Sequence Number: 1
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