MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY IV CATHETER-RADIOPAQUE 22G X 1 IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 10

Device Problem Leak/Splash (1354)

Patient Problem Bruise/Contusion (1754)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

Iv inserted without difficulty, was found to be leaking blood at the insertion site, pressure was held at the site, but continued to leak blood, iv was flushing well without infiltration.Iv was discontinued, catheter was noted to be intact.Upon further inspection of the hub and catheter it was found to have a leak at the connection between the catheter and the blue iv hub.Patient was found to have some bruising surrounding insertion site due to leaking during brief period the iv was in place.Pressure was held and hemostasis was achieved, gauze and bandaid in place.Fda safety report id # (b)(4).

• Brand Name: VIAVALVE SAFETY IV CATHETER-RADIOPAQUE 22G X 1 IN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12711592
• MDR Text Key: 279258692
• Report Number: MW5105005
• Device Sequence Number: 1
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: 10
• Device Lot Number: 4160896
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR