Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM; ANESTHESIOLGY
  • 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 EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM; ANESTHESIOLGY Back to Search Results
Catalog Number 100/391/818
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/04/2014
Event Type  malfunction  
Event Description
A report was received stating that the device was in use with a pt when it was observed that the catheter was found to be cut.A portion of the catheter remained in the pt.No surgical intervention required.No permanent adverse effects to the pt reported.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file follow-up report detailing the results of the evaluation once it is completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM
Type of Device
ANESTHESIOLGY
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
keene NH
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman drive
keene NH 03431
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4418932
MDR Text Key5165671
Report Number2183502-2014-01058
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeAS
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 01/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number100/391/818
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/23/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2015
Distributor Facility Aware Date12/04/2014
Event Location Hospital
Date Manufacturer Received12/15/2014
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
-
-