MAUDE Adverse Event Report: BECTON DICKINSON / DUBIN IRELAND BD PHASEAL "Y" SITE (C80); Y SITE CONNECTOR

Catalog Number 515304

Device Problems Backflow (1064); Chemical Spillage (2894); Connection Problem (2900)

Patient Problem No Information (3190)

Event Type  Other  

Event Description

"y" came apart while pt infusing 5fu @home.Rn met up with patient.Blood and chemo leaked back."y" extension had come apart where clear tubing is glued to hub.No harm to pt other than chemo spill clean up.Also delayed treatment and pt was sent to e.R.To make sure iv port was okay since it had backed up with blood.

• Brand Name: BD PHASEAL "Y" SITE (C80)
• Type of Device: Y SITE CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON / DUBIN IRELAND
• MDR Report Key: 4251383
• MDR Text Key: 21844090
• Report Number: MW5039023
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 515304
• Device Lot Number: 487901
• Patient Sequence Number: 1
• Patient Age: 78 YR