MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL JELCO ACUVANCE PLUS SAFETY IV CATHETER - RADIOPAQUE

Model Number	3357
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon discontinuing the iv in the left antecubital site, no catheter came with the hub.Dates of use: (b)(6) 2018.Diagnosis or reason for use: iv therapy.

• Brand Name: SMITHS MEDICAL JELCO ACUVANCE PLUS SAFETY IV CATHETER - RADIOPAQUE
• Common Device Name: IV CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7446357
• Report Number: MW5076571
• Device Sequence Number: 1642718
• Product Code: LJS
• UDI-Device Identifier: 10351688071453
• UDI-Public: 10351688071453
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 04/21/2020
• Device Model Number: 3357
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 91