MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML SYRINGE, PISTON

Model Number MY8060

Device Problem Fluid Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/19/2016

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 syringe leaked during a patient¿s doxorubicin infusion. The nurse had started the infusion, it started to drip at the port. She disconnected the syringe from the iv port, reconnected it and it still continued to drip. Pharmacy was notified and a new syringe with medication was provided. No patient or clinician harm was reported, the set was not sequestered, and no other event details are available.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 60 ML
• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6284865
• MDR Text Key: 66002142
• Report Number: 9616066-2017-00151
• 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: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/01/2019
• Device Model Number: MY8060
• Device Catalogue Number: MY8060
• Device Lot Number: D611901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/27/2017 Patient Sequence Number: 1

Treatment

PRI TUBING