MAUDE Adverse Event Report: BECTON DICKINSON AND CO. TEXIUM NEEDLE FREE SYRINGE D425905

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  Other  

Event Description

On 2016, i had a bd texium syringe that had a leak with 5fu in it.No patient was involved.This syringe was not used and a new 5fu dose was drawn up using another syringe.I have attached a picture of the syringe with the leak.It is a texium 10 ml needle free syringe.Item number: my8010 lot: d425905 exp: 09-2017.The leak occurred while pulling the 5fu into the syringe.The plunger rod was not pulled at an angle toward the user.Vertical alignment was maintained.(b)(6).

• Brand Name: TEXIUM NEEDLE FREE SYRINGE D425905
• Type of Device: TEXIUM NEEDLE FREE SYRINGE D425905
• Manufacturer (Section D): BECTON DICKINSON AND CO.
• MDR Report Key: 6144998
• MDR Text Key: 61563548
• Report Number: MW5066512
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1