MAUDE Adverse Event Report: SMITH-MEDICAL ASD INC. PROTECT IV PLUS SAFETY IV CATHETER; #22 G IV CATHETER

Model Number REF 3060

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2016

Event Type  malfunction  

Event Description

Right anticubital peripheral iv removed for discharge.When iv was removed catheter not attached to hub on iv.Pa notified.Pa and resident in room to perform us of right ac in order to visualize cath.

• Brand Name: PROTECT IV PLUS SAFETY IV CATHETER
• Type of Device: #22 G IV CATHETER
• Manufacturer (Section D): SMITH-MEDICAL ASD INC.; CT
• MDR Report Key: 5892956
• MDR Text Key: 52744227
• Report Number: MW5064215
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2016

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 Model Number: REF 3060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR