MAUDE Adverse Event Report: BECTON DICKINSON PHASEAL Y SITE CONNECTOR

Model Number C-80

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

My son gets 24 hrs infusion of chemotherapy.At (b)(6) hospital, they used a device called the becton dickinson phaseal you-site connector.Upon disconnection of the product chemotherapy leaked all over myself.I understand this happens at (b)(6) hospital as well.I understand that this product does not constitute a closed system transfer device.It is dangerous to the nurse, pt and family members at the bed side.Also it's hazardous spill.

• Brand Name: Y SITE CONNECTOR
• Type of Device: Y SITE CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON PHASEAL
• MDR Report Key: 3761671
• MDR Text Key: 4415366
• Report Number: MW5035702
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-80
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 18