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

Model Number MY8030

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: 250ml nacl bag and 500ml nacl bag; therapy date (b)(6) 2015.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported a doxorubicin leak while iv pushing the drug into the distal port of the iv line.The drug leaked out of the bonded junction of the texium syringe and the distal port of the iv line.Both disposables were leaking and the iv line had to be replaced.There was chemotherapy exposure to both patient and nurse; no harm reported.

Manufacturer Narrative

The customer¿s report of fluid leakage at the bonded end of a texium syringe during an iv push was not confirmed nor replicated.Visual inspection of the set noted no damage or anomalies.Functional testing was performed and no leaking was observed.The root cause of this failure was not identified.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE
• 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: 5220159
• MDR Text Key: 31008397
• Report Number: 9616066-2015-01526
• Device Sequence Number: 0
• Product Code: FMF
• 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: 10/23/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2016
• 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: 8100,8015,MY8030,SEC SET,10013361T