MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. JELCO® VIAVALVE® SAFETY IV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	328500
Medical Device Problem Code	Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
An emergency department nurse reported that a jelco® viavalve® safety iv catheter was difficult to thread forward, requiring two hands to get enough pressure for forward motion.This often results in "blowing the vein" and the "patient has to be stuck again".There was no patient injury associated with this occurrence.
Additional Manufacturer Narrative
One unused sample was returned for evaluation.Visual inspection and force testing were performed and found the device to be acceptable per specifications.Based on the evidence, a root cause was unable to be determined.No fault was found with the device.

• Brand Name: JELCO® VIAVALVE® SAFETY IV CATHETER
• 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 Key: 7232441
• Report Number: 3012307300-2018-00183
• Device Sequence Number: 11134221
• Product Code: FOZ
• UDI-Device Identifier: 10351688081933
• UDI-Public: 10351688081933
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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 Date: 10/03/2019
• Device Catalogue Number: 328500
• Device Lot Number: 3493146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1