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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

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SMITHS MEDICAL ASD, INC. JELCO® VIAVALVE® SAFETY IV CATHETERS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 326710
Device Problems Leak/Splash (1354); 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 was difficult to thread and exhibited leaking at the valve. No adverse patient effects were reported.
 
Manufacturer Narrative
One jelco® viavalve® safety iv catheter was returned for analysis. The customer's reported problem was "the ivc was not threading properly and valve leaking. " the catheter sub-assembly was not included; so the valve could not be evaluated. Blood was present in the guard. It 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. When manually advancing the assembly with slight downward pressure to simulate clinical use, it was observed that advancement was difficult and uneven in feel. However, this may be due to the presence of blood residue. Regarding the leakage, based on these observations and the lack of a beveled acam to examine, it is unconfirmed that the complaint was due to a manufacturing non-conformance. Regarding the threading complaint, based on these observations the presence of it is unconfirmed that the complaint was due to a manufacturing non-conformance. The manufacturing processes were reviewed and considered adequate and correct.
 
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Brand NameJELCO® VIAVALVE® SAFETY IV CATHETERS
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 Key7430536
MDR Text Key105459443
Report Number3012307300-2018-01163
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 company representative,health
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 Received04/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2019
Device Catalogue Number326710
Device Lot Number3496130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
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 Manufactured09/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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