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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD CONTINUOUS EPIDURAL TRAY

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CAREFUSION, INC BD CONTINUOUS EPIDURAL TRAY Back to Search Results
Catalog Number 400840
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Device expiration date: unknown. Device manufacture date: unknown. 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 a 18gx3. 5 weiss 20g ce,5ml lor ll,27g hyp had a difficult epidural connector. The following was reported, "material no. : 400840. Batch/lot: unknown/ not provided. It was reported that "providers are having issues with the epidural connector - it¿s difficult to put on the epidural line to the point where it¿s been falling off the line and issues of the provider tightening it too much which has been constricting the line not allowing the medicine to go through the line. ".
 
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Brand NameBD CONTINUOUS EPIDURAL TRAY
Type of DeviceEPIDURAL TRAY
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 Key8493792
MDR Text Key141448374
Report Number1625685-2019-00020
Device Sequence Number0
Product Code CAZ
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400840
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 Received03/20/2019
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: 04/08/2019 Patient Sequence Number: 1
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