MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE 30ML; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MY8030

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported a leak occurred between the texium site on a syringe (30cc) and the smartsite located on a y-site closest to the patient of a saline infusion set.Approximately 1-2 ml of doxorubicin leaked while it was given iv push.The leak was controlled with gauze and the dose was given.No patient or staff harm reported.

Manufacturer Narrative

The customer¿s report of a leak was confirmed upon inspection but not replicated.Upon inspection, the outside of the texium luer on the syringe and the distal y-port on the concomitant iv set contained dried red colored fluid.Closer inspection detected a gap between the texium luer tip on the syringe and the smartsite y-port.The texium syringe was tightened onto the smartsite y-port and the gap closed.No other issues or damages were identified.Functional testing was performed and no leaking was observed.The root cause of the reported leak was not identified.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE 30ML
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 5261150
• MDR Text Key: 32509070
• Report Number: 9616066-2015-01649
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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