MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Lot Number 3876260

Device Problems Defective Component (2292); Connection Problem (2900)

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

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Faulty abg syringes do not connect to tulip arterial line access devices nor to the syringe caps.This is an exposure risk to staff as well as a patient safety risk due to potential unintended blood loss via arterial line during access attempts.Recurring problem.Staff reporting this did not provide any specific patient information.They mentioned this has happened several times.

• Brand Name: PORTEX
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9347119
• MDR Text Key: 167174411
• Report Number: 9347119
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3876260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1