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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/116CZ1
Device Problems Material Fragmentation (1261); Occlusion Within Device (1423); Deformation Due to Compressive Stress (2889)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
It was reported that the epidural catheter kinked upon insertion, and therefore prevented injection of the drug. There were three separate occurrences of this situation. One required complete removal of the catheter and replacement with a new one. Two required withdrawal of the catheter to enable injection. The consequence to the patient was described as follows: "the patient had to return to theatre for a second procedure to see if they could locate the catheter tip. ".
 
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Brand NamePORTEX EPIDURAL CONTINUOUS TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL CZECH REPUBLIC A. S.
olomoucká 306
hranice 1 - mesto
hranice, 75301
EZ 75301
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7537123
MDR Text Key109017565
Report Number3012307300-2018-01789
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K062005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100/391/116CZ1
Device Lot Number3573303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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