MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; SYRINGE, ANTISTICK

Model Number 4043-2

Device Problem Material Puncture/Hole (1504)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/06/2018

Event Type  malfunction  

Event Description

I drew an arterial blood gas (abg) from the patient's arterial line.There was a hole in the abg syringe, and when i pushed the blood into the cap, i was sprayed in the face with blood.

• Brand Name: PORTEX
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 8068500
• MDR Text Key: 127116178
• Report Number: 8068500
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2018

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
• Device Operator: Health Professional
• Device Model Number: 4043-2
• Device Lot Number: 3668390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other