MAUDE Adverse Event Report: CAREFUSION EXTENSION TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number EXT TUBING

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Unintended System Motion (1430)

Patient Problem No Information (3190)

Event Date 10/26/2019

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

It was reported that a patient receiving videza went to the bathroom, and the short tubing, which was attached to the chemo tubing below the pump module got caught on an unspecified object and snapped."since texium was still on the chemo tubing" videza back flowed from the texium product which spilled approximately 10ml on the floor.This occurred in the infusion center.

• Brand Name: EXTENSION TUBING SET
• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9536263
• MDR Text Key: 191991241
• Report Number: 9616066-2019-03804
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXT TUBING
• Device Catalogue Number: EXT TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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