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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 Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
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 an unspecified number of tray epid cont we18g3. 5 c20 lor5 s/l/l-e experienced a mix of product types in a pack which was noted prior to use. The following information was provided by the initial reporter: material no: 406047 batch no: 0001285103. Voicemail received which mentioned an issue with item 406047. The voicemail cut in an out but it seems that one of the components in the tray is not correct.
 
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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 Key8838906
MDR Text Key198924585
Report Number1625685-2019-00079
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 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received07/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/29/2019 Patient Sequence Number: 1
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