MAUDE Adverse Event Report: BECTON DICKINSON PEN LIMITED BD PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number 515070

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

Patient was receiving chemotherapy and tubing came unattached at pharmacy non-drip tubing site.According to patient, nothing felt wet on his skin.But, a few drops of the chemotherapy medication were found on sheet and about a 4-inch circle found on (b)(6).Patient's skin appeared dry, and gown was dry.

• Brand Name: BD PHASEAL OPTIMA
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON PEN LIMITED; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 13522768
• MDR Text Key: 285538591
• Report Number: 13522768
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 515070
• Device Lot Number: 2104501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male