• 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 EPIDURAL FILTER, FLAT WITH LUER LOCK FILTER, CONDUCTION, ANESTHETIC

  • 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 EPIDURAL FILTER, FLAT WITH LUER LOCK FILTER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number 100/386/010
Device Problems Fluid Leak (1250); Defective Component (2292); Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Type  malfunction  
Manufacturer Narrative
Foreign - report source: (b)(6).
 
Event Description
Information was received that the soldered coupling of a smiths medical portex epidural filter, flat with luer lock was released, causing the connection on the eda filter to break during patient infusion. It was also noted there was a small leakage next to the hose. Subsequently, the patient experienced breakthrough pain, but no additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK
Type of DeviceFILTER, CONDUCTION, ANESTHETIC
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 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8755048
MDR Text Key149930717
Report Number3012307300-2019-02847
Device Sequence Number1
Product Code BSN
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K083451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100/386/010
Device Catalogue Number100/386/010
Device Lot Number3633743
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-