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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 406047
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2019
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.
 
Event Description
It was reported that 2 trays epid cont we18g3. 5 c20 lor5 s/l/l-e were found before use with 19g epidural catheters, rather than the 20g catheters indicated on the labeling. The following information was provided by the initial reporter: "our anesthesia group is coming across a component discrepancy. Bd continuous epidural tray 406047 is labeled as having a 20g x36 in epidural catheter. We have two trays that came with 19g. ".
 
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Brand NameTRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
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 Key8981156
MDR Text Key195565995
Report Number1625685-2019-00107
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 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number406047
Device Lot Number0001285103
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2019
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: 09/10/2019 Patient Sequence Number: 1
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