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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPAK, EPIDURAL ANESTHESIA SYSTEM; CAZ-ANESTHESIOLGY
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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPAK, EPIDURAL ANESTHESIA SYSTEM; CAZ-ANESTHESIOLGY Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Event Description
A report was received that upon removal of catheter a piece was discovered to be missing.Ct scan was unable to locate the missing catheter segment.No medical intervention was taken to remove the missing segment.No permanent adverse effects to the patient reported.
 
Manufacturer Narrative
\additional mfr narrative: smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a f/u report detailing the results of the evaluation once it is completed.
 
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Brand Name
PORTEX EPIDURAL MINIPAK, EPIDURAL ANESTHESIA SYSTEM
Type of Device
CAZ-ANESTHESIOLGY
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
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 Key4613850
MDR Text Key20786657
Report Number2183502-2015-00121
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
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 03/06/2015,09/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/20/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2015
Event Location Hospital
Date Manufacturer Received02/17/2015
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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