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. JELCO® VIAVALVE® SAFETY IV CATHETERS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
  • 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. JELCO® VIAVALVE® SAFETY IV CATHETERS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 326010
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that this peripheral intravenous catheter exhibited a drag upon threading.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JELCO® VIAVALVE® SAFETY IV CATHETERS
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7651998
MDR Text Key112849828
Report Number3012307300-2018-02562
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier15019517078398
UDI-Public15019517078398
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 06/29/2018
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 No Information
Device Expiration Date03/17/2020
Device Catalogue Number326010
Device Lot Number3584452
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/11/2018
Initial Date FDA Received06/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2018
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
-
-