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® SPINAL ANESTHESIA TRAY; 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® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4037-25
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code Awareness during Anaesthesia (1707)
Date of Event 11/29/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2017-2535.
 
Event or Problem Description
It was reported that there was questionable potency (of marcaine) in face of a single pass easy placement of a spinal needle from a portex® spinal anesthesia tray.The patient had no motor block and required more intra-operative medications.This is consistent with bad marcaine.Marcaine is a local anesthetic.No adverse events were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX® SPINAL ANESTHESIA TRAY
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7106138
Report Number3012307300-2017-02536
Device Sequence Number1235377
Product Code CAZ
UDI-Device Identifier20351688080339
UDI-Public20351688080339
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date03/01/2019
Device Catalogue NumberA4037-25
Device Lot Number3516651
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2017
Supplement Date Received by Manufacturer01/06/2018
Initial Report FDA Received Date12/11/2017
Supplement Report FDA Received Date01/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-