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: ST PAUL PORTEX; PAIN MANAGEMENT
  • 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; PAIN MANAGEMENT Back to Search Results
Catalog Number NEPI-49661C-25
Device Problem Peeled/Delaminated (1454)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/07/2021
Event Type  Injury  
Manufacturer Narrative
No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.
 
Event Description
Information received a smiths medical epidural spinal needle during a knee replacement it malfunctioned and broke off.The anesthesia was placed in the spinal needle broke off in the patients back and had to be removed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX
Type of Device
PAIN MANAGEMENT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11916917
MDR Text Key253685637
Report Number3012307300-2021-05369
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 user facility
Type of Report Initial
Report Date 06/01/2021
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
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Catalogue NumberNEPI-49661C-25
Device Lot Number4081849
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/03/2021
Initial Date FDA Received06/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-