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

Model Number 515056

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

Patient was post-hydrating with normal saline solution (nss) following carboplatin.I was at the bedside and patient was sitting on mother's lap, not touching the tubing.The injector piece disconnected from the connector piece on the patient¿s port.

• Brand Name: BD PHASEAL OPTIMA CLOSED SYSTEM DRUG TRANSFER DEVICE - INJECTOR (N40-O)
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON PEN LIMITED; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12142169
• MDR Text Key: 260708166
• Report Number: 12142169
• Device Sequence Number: 1
• Product Code: ONB
• 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: 07/02/2021

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: No Information
• Device Model Number: 515056
• Device Catalogue Number: 515056
• Device Lot Number: 2009603
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA