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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM; ANESTHESIOLOGY
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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM; ANESTHESIOLOGY Back to Search Results
Catalog Number 100/391/019
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/12/2014
Event Type  malfunction  
Event Description
A report received stating that the device was in use with a patient when it was observed that the catheter was found to be cut.A portion of the catheter remained in the patient and was removed without requiring surgical intervention.No permanent adverse effects to the 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.
 
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Brand Name
PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM
Type of Device
ANESTHESIOLOGY
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 Key4168999
MDR Text Key5019680
Report Number2183502-2014-00520
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number100/391/019
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/23/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2014
Distributor Facility Aware Date05/12/2014
Event Location Hospital
Date Manufacturer Received07/04/2014
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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