• 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 CATHETER 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 CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 326800
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This device is same and/or similar to a device approved for distribution in the us.
 
Event Description
It was reported that the packaging of a jelco® viavalve® safety iv catheter was white with no orange strip. No injury was reported.
 
Manufacturer Narrative
The complainant returned two "5 up strips" that were missing the 14ga "orange color bar" for evaluation. Upon reviewing the two strips, they were confirmed to be cavity #'s 1-5 and 6-0, which represented one full machine cycle. In the packaging operation, 10 blister packages are produced simultaneously. The investigation did confirm that the product failed to meet the expected performance as a result of a manufacturing related issue. Device history record was reviewed. The product was packaged on ffs #11 on the 22nd of april 2017. No discrepancies or abnormalities relevant to the complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJELCO® VIAVALVE® SAFETY IV CATHETER
Type of DeviceCATHETER,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 Key7389942
MDR Text Key104192376
Report Number3012307300-2018-00899
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10351688077851
UDI-Public10351688077851
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2019
Device Catalogue Number326800
Device Lot Number3417549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-