• 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 MAXIPACK 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® EPIDURAL MAXIPACK ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number MAXL181
Device Problem Material Deformation (2976)
Patient Problem Headache (1880)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Four unopened sets of portex® epidural maxipack were provided for analysis in which the tuohy needle was included. The used sample was not provided. The customer's reported problem was "patient injury due to a burr in the area of the tip of the tuohy needle". The four included touhy needles were visually inspected, but no deviations were found. The tuohy needle tip was visually inspected under a microscope. No burr or deviation was detected on all 4 samples. In the device history record (dhr), there is no hint of such a failure. The quality inspection processes were reviewed and considered adequate and correct. Investigation was unable to confirm the customer's reported problem.
 
Event Description
It was reported that there was a patient injury due to a burr in the area of the tip of the tuohy needle from a portex® epidural maxipack. The alleged injury to the dura mater spinalis and thus necessary blood patch due to cerebrospinal fluid (csf) leak. The patient complained post-op about headaches. No other patient injury was reported.
 
Manufacturer Narrative
Four unopened portex® epidural maxipack kits were returned, which contain tuohy needle (b)(4), for analysis. No deviations were noted upon visual exam. A microscope was used to further investigate the tuohy needle tip; no deviations detected. Based on the evidence, the complaint was not confirmed as no fault was found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX® EPIDURAL MAXIPACK
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 DEUTSCHLAND GMBH
hauptstrasse 45-47
kirchseeon, 85614
GM 85614
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7716396
MDR Text Key114929951
Report Number3012307300-2018-02913
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Catalogue NumberMAXL181
Device Lot Number3559357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/24/2018 Patient Sequence Number: 1
-
-