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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CATHETER

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CAREFUSION, INC BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CATHETER Back to Search Results
Catalog Number 400841
Device Problems Loose or Intermittent Connection (1371); Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ continuous epidural tray: bd perisafe¿ nylon epidural catheter had loose closure at the connection with the catheter allowing the connection to separate. No serious injury or medical intervention was reported.
 
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Brand NameBD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT CATHETER
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
8015652845
MDR Report Key7789784
MDR Text Key117569736
Report Number1625685-2018-00034
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400841
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
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: 08/16/2018 Patient Sequence Number: 1
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