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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL VIAVALVE SAFETY IV CATHETER

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SMITHS MEDICAL VIAVALVE SAFETY IV CATHETER Back to Search Results
Model Number 22G X 1"
Device Problem Difficult to Insert (1316)
Patient Problem Rupture (2208)
Event Date 08/01/2017
Event Type  Injury  
Event Description
Nurse reported it was very difficult to pierce the patient's skin with the iv catheter, when it did insert, the vein blew immediately. This happened on 2 more pts with this lot number, so you will see a total of 3 similar reports.
 
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Brand NameVIAVALVE SAFETY IV CATHETER
Type of DeviceVIAVALVE SAFETY IV CATHETER
Manufacturer (Section D)
SMITHS MEDICAL
minneapolis MN
MDR Report Key6773352
MDR Text Key82328856
Report NumberMW5071422
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22G X 1"
Device Lot Number3343112
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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