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

Model Number MY8060

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported a "leak out the back of the syringe" during an iv push of adriamycin.The medication leaked out of the "stopper" (plunger) onto the nurse.No patient and/or user 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: 5250662
• MDR Text Key: 32145376
• Report Number: 9616066-2015-01671
• 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: MY8060
• Device Catalogue Number: MY8060
• 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