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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD 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 07/25/2019
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 incorrect needle length was in the tray with a bd tray epid cont we18g3. 5 c20 lor5 s/l/l-e. This occurred on 2 separate occasions prior to use. The following information was provided by the initial reporter: it was reported that two trays contained the incorrect needle length. Health care professional called to report that doctor found 2 kits that had 19 g instead of 20g lot is unknown.
 
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Brand NameBD TRAY 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 Key8895032
MDR Text Key216599093
Report Number1625685-2019-00090
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number406047
Device Lot NumberUNKNOWN
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 Received07/25/2019
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: 08/14/2019 Patient Sequence Number: 1
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