MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL OPTIMA INJECTOR N40-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number 515056 21-15399

Device Problems Disconnection (1171); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 07/16/2021

Event Type  Injury  

Event Description

A (b)(6) year old (midas 21-15399) patient was hooked up to ivf with a chemo ivf line that had a phaseal optima device on the end per policy.Approx 2 hours into the infusion, device disconnected from the patients mediport line.Pump alerted and beeped "occluded" line was cleaned appropriately and ivf line reattached to patient.Fda safety report id# (b)(4).

• Brand Name: BD PHASEAL OPTIMA INJECTOR N40-O
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12287728
• MDR Text Key: 265790115
• Report Number: MW5103057
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 515056 21-15399
• Device Catalogue Number: 515056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR