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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 Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
See mfr: 3012307300-2018-00833, 3012307300-2018-00879, 3012307300-2018-00880, 3012307300-2018-00881, 3012307300-2018-00882, 3012307300-2018-00883.
 
Event Description
It was reported that the smiths medical device "blood return big veins" and the device was hard to slide.It was indicated that a nurse blew a vein.No other information was provided.
 
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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 Key7381762
MDR Text Key103834961
Report Number3012307300-2018-00881
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier15019517078435
UDI-Public15019517078435
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 Other
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date01/19/2020
Device Catalogue Number326710
Device Lot Number3564888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2018
Was the Report Sent to FDA? No
Date Manufacturer Received03/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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