MAUDE Adverse Event Report: SMITHS MEDICAL PROTECTIV PLUS-W SAFETY IV CATHETER

Model Number 3087

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

Patient Problem No Information (3190)

Event Date 03/02/2017

Event Type  Injury  

Event Description

An iv was attempted with a 20ga x 1" protectiv plus catheter.Upon retraction of the needle, the catheter broke off.A ct of the lue and chest was performed but the catheter was not able to be visualized.

• Brand Name: PROTECTIV PLUS-W SAFETY IV CATHETER
• Type of Device: PROTECTIV PLUS-W SAFETY IV CATHETER
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6475484
• MDR Text Key: 72422909
• Report Number: MW5068989
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3087
• Was Device Available for Evaluation?: No
• 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: 42 YR