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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL TRAY; CAZ-ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL TRAY; CAZ-ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A3624-17
Device Problem Material Fragmentation (1261)
Patient Problem Therapy/non-surgical treatment, additional (2519)
Event Date 01/15/2014
Event Type  malfunction  
Event Description
According to user facility, the catheter was difficult to remove from patient.After removal from patient, tip of catheter was observed to be missing.The tip of the catheter was then found inside the epidural needle.No adverse effects to patient reported.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.The actual device involved was returned and is currently under evaluation.
 
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Brand Name
PORTEX CONTINUOUS EPIDURAL TRAY
Type of Device
CAZ-ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
keene NH
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman drive
keene NH 03431
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3881217
MDR Text Key4570028
Report Number2183502-2014-00027
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 Other
Type of Report Initial
Report Date 02/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA3624-17
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/30/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2014
Distributor Facility Aware Date01/15/2014
Event Location Hospital
Date Manufacturer Received01/15/2014
Was Device Evaluated by Manufacturer? No
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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