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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD PORTEX CONTINUOUS EPIDURAL TRAY; CAZ- ANESTHESIA CONDUTION KIT
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SMITHS MEDICAL ASD PORTEX CONTINUOUS EPIDURAL TRAY; CAZ- ANESTHESIA CONDUTION KIT Back to Search Results
Catalog Number 4934-18
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/05/2014
Event Type  malfunction  
Event Description
According to user facility, following removal the tip of the catheter was observed to have broken off and remained inside the patient's epidural space.The tip of the catheter was not retrieved.No adverse effects to patient reported.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a f/u report detailing the results of the evaluation once it is completed.
 
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Brand Name
PORTEX CONTINUOUS EPIDURAL TRAY
Type of Device
CAZ- ANESTHESIA CONDUTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD
keene NH
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman dr
keene NH 03431
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4368111
MDR Text Key5235184
Report Number2183502-2014-00994
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Catalogue Number4934-18
Device Lot Number2578463
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/26/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2014
Distributor Facility Aware Date11/05/2014
Device Age1 YR
Event Location Hospital
Date Manufacturer Received11/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/10/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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