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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 Problems Difficult to Insert (1316); Dull, Blunt (2407)
Patient Problems Pain (1994); Rupture (2208)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
Thirty unused smiths medical jelco® viavalve® safety iv catheters were returned for analysis. All samples were visually assessed under magnification and were found to be acceptable with no needle point or catheter bevel tip irregularities. In-process product was inspected by using statistically valid sampling plans at defined intervals. If any nonconformance's are found in process, the product is isolated, non-conformed and immediate corrective action is taken. Based on the evidence, there were no faults found.
 
Event Description
Information was received indicating that a smiths medical jelco® viavalve® safety iv catheter appeared to be blunt with increased resistance on insertion into the skin causing increased pain. It was noted that the bluntness of the iv caused the vein wall to burst; not achieving iv access. There were no reported adverse effects.
 
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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 n
minneapolis,, MN 55442
7633833310
MDR Report Key7533669
MDR Text Key108903221
Report Number3012307300-2018-01625
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2020
Device Catalogue Number326710
Device Lot Number3584504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2018
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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