• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CATHETERS 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
 

ST PAUL PORTEX EPIDURAL CATHETERS ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Disconnection (1171)
Patient Problem Pain (1994)
Event Date 03/08/2021
Event Type  malfunction  
Event Description
It was reported that the patient experienced a lack of pain relief because the catheter had become disconnected from the yellow connector/filter. The patient was in labor when this issue occurred and experienced acute pain. No further patient complications were reported in relation to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX EPIDURAL CATHETERS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11671432
MDR Text Key245575054
Report Number3012307300-2021-03171
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,other,user facility
Type of Report Initial
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-