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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 326510
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/31/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Please see mfr # 3012307300-2018-02490 and 3012307300-2018-02492 for related device incidents.
 
Event or Problem Description
It was reported that a user facility had difficulty starting an iv due to the needle appearing dull and the catheter not advancing.No patient injury was reported.
 
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Brand Name
JELCO® VIAVALVE® SAFETY IV CATHETERS
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7643414
Report Number3012307300-2018-02491
Device Sequence Number16619119
Product Code FOZ
UDI-Device Identifier15019517078411
UDI-Public15019517078411
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160235
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/25/2020
Device Catalogue Number326510
Device Lot Number3584464
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date06/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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