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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY CATHETER, INTRAVASCULAR, THERAPEUTIC

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SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Lot Number 3756739
Device Problems Crack (1135); Fluid Leak (1250); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2019
Event Type  malfunction  
Event Description
As rn placed piv in right antecubital, the catheter bent and developed a crack that resulted in a leak making it ineffective. Rn assured catheter was completely removed.
 
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Brand NameVIAVALVE SAFETY
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9271414
MDR Text Key164837928
Report Number9271414
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3756739
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2019
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer11/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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