MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE; SYRINGE, PISTON

Model Number MY8030

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

The customer reported that the texium syringe leaked 5fu medication from the bonded connection between the syringe and the texium component during an iv push.No patient harm reported.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5250659
• MDR Text Key: 32145143
• Report Number: 9616066-2015-01670
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MY8030
• Device Catalogue Number: MY8030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRI TUBING