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

Model Number MY8060

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint of a leak between the texium and the iv set port was confirmed per picture received by customer.Red droplets of fluid were observed on the male luer portion of the texium.The root cause of this failure was not identified.

Event Description

The customer reported a leak of adriamycin of unspecified dosage during administration.The clinician in attendance noted the leak between the texium and the iv set port.She reconnected to attempt to complete the infusion and when the leak continued, she returned the syringe to the pharmacy.A new syringe was prepared and the infusion was completed without incident.The pharmacist noted that there was no leak noted during the preparation of the syringe and cannot specify the interval of time between preparation and administration.There is no report of patient harm.

Manufacturer Narrative

(b)(4).

• 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: 5319298
• MDR Text Key: 34808758
• Report Number: 9616066-2015-01843
• 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
• Report Date: 12/01/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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
• Date Manufacturer Received: 04/22/2016
• 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