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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO VIAVALVE SAFETY IV CATHETER - RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD, INC JELCO VIAVALVE SAFETY IV CATHETER - RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 20 G X 1 INCH
Device Problems Fluid/Blood Leak (1250); Activation Problem (4042)
Patient Problems Infiltration into Tissue (1931); Pain (1994)
Event Date 02/23/2021
Event Type  Injury  
Event Description
Smiths medical jelco 20g x 1 inch viavalve safety iv catheter issue.Nurse received patient with two ivs: left hand and left ac - left hand was infiltrated, left ac was leaking; both lines placed only hours prior.New iv placed in right ac - minutes later iv infiltrated, causing pain to patient.New iv placed in right upper arm - an hour later iv infiltrated, causing pain and frustration to patient.New iv placed in left hand - heplocked.Patient very frustrated with situation.Multiple experienced staff members involved with placing ivs.Fluids mandatory due to hypotension - multiple mds had to be contacted during middle of the night because of inconsistent iv access.Fda safety report id # (b)(4).
 
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Brand Name
JELCO VIAVALVE SAFETY IV CATHETER - RADIOPAQUE
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
MDR Report Key11392000
MDR Text Key234256665
Report NumberMW5099675
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/24/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number20 G X 1 INCH
Device Lot Number4068754
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/26/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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