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

Catalog Number	326510
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unused peripheral intravenous catheter was received for analysis.This was not the same product used in the complaint, however this unused sample was from the same lot number.This sample was tested based on the complaint issue.The take off force, or the initial force that separates the tip of the catheter from the needle, as well as the force to advance, the force required to advance the device tab until locking, were both tested.The resulting values were within specification.Without evaluating the actual sample, it cannot be assessed or confirmed whether a quality related issue has resulted in the user's reported difficulties.The device history record was reviewed and no manufacturing or testing issues were found.Based on the evidence, the complaint was confirmed.
Event or Problem Description
Information was received indicating that this peripheral intravenous catheter was dragging upon threading the needle.The difficult insertion caused veins to blow and required additional pokes.No adverse patient effects were reported.

• 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 Key: 7579589
• Report Number: 3012307300-2018-02078
• Device Sequence Number: 19272280
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/07/2018

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: Nurse
• Device Expiration Date: 01/16/2020
• Device Catalogue Number: 326510
• Device Lot Number: 3529456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/07/2018
• Patient Sequence Number: 1