MAUDE Adverse Event Report: BECTON DICKINSON & CO. IV EXTENSION SET PRIMARY TUBING SET WITH 2-WAY VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PART # 2420-0500

Device Problems Contamination (1120); Disconnection (1171)

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

Event Date 08/02/2019

Event Type  Injury  

Event Description

The iv tubing was connected to a pt infusing oxytocin, and during delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and all iv tubing to become contaminated resulting in the pt requiring a new iv site and new tubing and meds to be started on a pt during delivery.Fda safety report id# (b)(4).

• Brand Name: IV EXTENSION SET PRIMARY TUBING SET WITH 2-WAY VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 8927163
• MDR Text Key: 155506194
• Report Number: MW5089272
• Device Sequence Number: 1
• Product Code: FPA
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PART # 2420-0500
• 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