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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH 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 09/10/2019
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. 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. Device manufacture date: unknown.
 
Event Description
It was reported that epidural tray perisafe continuous tuohy 18 gauge 3-1/2 inch had the wrong catheter inside the tray. This was discovered before use. The following information was provided by the initial reporter: material no: 406047 batch no: unknown. It was reported that the wrong catheter was inside the tray.
 
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Brand NameEPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH
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 Key9117411
MDR Text Key206941453
Report Number1625685-2019-00114
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904060473
UDI-Public00382904060473
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received09/10/2019
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: 09/25/2019 Patient Sequence Number: 1
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