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

Model Number 515056

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  Injury  

Event Description

(b)(6) (midas number (b)(4)): chemotherapy tubing became disconnected while running mtx.Tubing became disconnected at injector site with the tubing laying on the floor and connector was still attached to patients port with blood running out of port.About 10 mls of chemotherapy was lost and on the floor.Physician notified.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: 12293607
• MDR Text Key: 265971274
• Report Number: MW5103062
• 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: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 515056
• 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: 6 YR