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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BC CONTINUOUS EPIDURAL TRAY; EPIDURAL CATHETER

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BECTON, DICKINSON AND COMPANY BC CONTINUOUS EPIDURAL TRAY; EPIDURAL CATHETER Back to Search Results
Model Number 406310
Device Problems Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2014
Event Type  malfunction  
Event Description
Epidural catheter inserted and functioning properly for test dose.When trying to inject a dose post-op catheter was occluded.Feeling that the catheter was dislodged the catheter was removed.Upon inspection of the catheter the connector was obstructed-product defect.(b)(4).
 
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Brand Name
BC CONTINUOUS EPIDURAL TRAY
Type of Device
EPIDURAL CATHETER
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
franklin lakes NJ 07417
MDR Report Key3685307
MDR Text Key4240476
Report NumberMW5034956
Device Sequence Number1
Product Code BSO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number406310
Device Catalogue NumberDGW111303
Other Device ID Number(01)0038290406308
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/12/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
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