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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

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SMITHS MEDICAL, ASD, INC. JELCO® VIAVALVE® SAFETY IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 326310
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that when the needle of a jelco® viavalve® safety iv catheter was inserted and hub removed, blood started. No report of patient injury.
 
Manufacturer Narrative
One used peripheral intravenous catheter was returned for analysis with a locked out needle guard sub-assembly. The catheter sub-assembly was not included so the valve could not be evaluated. The sample had blood residue in the flash chamber, nose and guard. Blood present in the guard is indicative that the deployment chassis was left attached to the catheter hub for a longer than necessary time. The beveled acam which houses the seal was not returned for evaluation. T would appear that the excessive presence of blood may be a deployment training issue as the deployment chassis would have to be left attached to the catheter hub for a long period of time for the amount of blood to leak. Based on these observations and the lack of a beveled catheter assembly to examine, the complaint cannot be confirmed.
 
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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
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7492553
MDR Text Key107566203
Report Number3012307300-2018-01275
Device Sequence Number1
Product Code FOZ
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/06/2019
Device Catalogue Number326310
Device Lot Number3423953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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