• 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® NEEDLELESS 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® NEEDLELESS SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 15548-20
Device Problem Missing Value Reason (3192)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/16/2014
Event Type  malfunction  
Manufacturer Narrative
The anesthetic is a supplied item and the complaint notification was forwarded to the supplier. Batch record review performed by the supplier for bupivacaine lot # 31496ev revealed no discrepancies that may have contributed to a complaint of this nature. Retained file samples were tested for product potency. The results of potency testing met specification. See (b)(6) evaluation report. Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
 
Event Description
It was reported that during use of a portex® needleless spinal anesthesia tray the drugs bupivacaine and dextrose was ineffective resulting in incomplete blocks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX® NEEDLELESS SPINAL ANESTHESIA TRAY
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
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7507767
MDR Text Key108147489
Report Number3012307300-2018-10001
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2015
Device Catalogue Number15548-20
Device Lot Number2739406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/05/2015
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 Initial

-
-