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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Patient Problems Infiltration into Tissue (1931); Perforation (2001)
Event Type  malfunction  
Manufacturer Narrative
Date of event: possible event date (b)(6) 2018.
 
Event Description
Information was received that a smiths medical portex epidural catheter was too stiff, causing vascular penetration. No additional adverse patient effects were reported.
 
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Brand NamePORTEX EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8276019
MDR Text Key134063793
Report Number3012307300-2019-00367
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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