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. SMITHS MEDICAL PORTEX SPINAL SINGLE SHOT TRAYS; 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. SMITHS MEDICAL PORTEX SPINAL SINGLE SHOT TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EPX1364/100JP
Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
Information was received that while a smiths medical portex spinal single shot trays was in use, the customer found a crack in the inflation line, from which air was leaking.No patient injury resulted.
 
Manufacturer Narrative
Additional information was received indicating the lot number of the product upon return to manufacturer for analysis.
 
Manufacturer Narrative
Investigation result completed on a smith medical pain management portex spinal single shot tray.The spinal anesthesia needle was visualized upon inspection bent about five degrees.Further devices from same lot were evaluated and found no discrepancy noted.The isolated event is believed to be caused from during manufacturing.
 
Event Description
Device analysis completed and will be updated in h 10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMITHS MEDICAL PORTEX SPINAL SINGLE SHOT TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key9292961
MDR Text Key175755622
Report Number3012307300-2019-06324
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberEPX1364/100JP
Device Lot Number190508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Date Manufacturer Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-