• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD INC., PORTEX CONTINUOUS EPIDURAL ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4138-17
Device Problem Material Integrity Problem (2978)
Patient Problem Awareness during Anaesthesia (1707)
Event Type  malfunction  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
The user facility reported that an epidural catheter was in use with a patient when its plastic sheared off and its internal wiring was exposed. According to the reporter, the catheter was removed normally; it was removed from patient's back by hand. The reporter explained that the patient was provided regional anesthesia as a result of the epidural catheter damage. No permanent injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX CONTINUOUS EPIDURAL
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.,
10 bowman drive
keene NH 03431 0724
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
michele seliga
1265 grey fox rd.
st. paul, MN 55112
7633833052
MDR Report Key5551507
MDR Text Key41991341
Report Number2183502-2016-00736
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 04/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA4138-17
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-