MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL ; VIAVALVE SAFETY IV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT

Lot Number 3584460

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 04/17/2018

Event Type  Injury  

Event Description

When removing the iv site it was noted that the catheter was broken off from the hub.

• Brand Name: SMITHS MEDICAL
• Type of Device: VIAVALVE SAFETY IV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; southington CT 06489
• MDR Report Key: 7450508
• MDR Text Key: 106300878
• Report Number: MW5076636
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Lot Number: 3584460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84