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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 3260
Device Problems Difficult to Advance (2920); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that a smiths medical device was hard to thread. It was noted that the device locked up causing the nurse to miss the patient. No injury was reported.
 
Manufacturer Narrative
One used deployment chassis was received for investigation. Examination of the returned deployment chassis did not reveal any abnormalities. The deployment chassis moved freely and locked normally. No beveled catheter assembly was returned to evaluate the complete device for deployment efficacy and or replication of deployment in a vein pad.
 
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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 Key7430902
MDR Text Key105520917
Report Number3012307300-2018-01162
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2018
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 Date12/05/2019
Device Catalogue Number3260
Device Lot Number3541906
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 Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2017
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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