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 COMBINED SPINAL-EPIDURAL MINIPACK
  • 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 COMBINED SPINAL-EPIDURAL MINIPACK Back to Search Results
Catalog Number 100/491/816
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/17/2020
Event Type  Injury  
Event Description
According to the reporter the epidural catheter sheared off 6 cm from the end.The reporter stated the issue occurred during insertion into patient.The reporter stated the catheter could not be visualized at the skin and 6 cm remained in patient.The user facility performed an mri examination of total spine; no evidence of foreign body was seen.No hematoma identified.The reporter also stated "no significant canal compromise or cord signal abnormality.No evidence of acute bony injury or bone destruction.No neurology." no further adverse effects to patient reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX COMBINED SPINAL-EPIDURAL MINIPACK
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10916031
MDR Text Key218636337
Report Number3012307300-2020-11887
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K924541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number100/491/816
Device Lot Number3707520
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2020
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-