MAUDE Adverse Event Report: CAREFUSION, INC CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS; WARMER, THERMAL, INFUSION FLUID

Catalog Number 980202EU

Device Problem Disconnection (1171)

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

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: the customer has confirmed that there is no sample available and the lot number is unknown.If any additional information becomes available a follow up submission will be filed.(b)(4).

Event Description

The cartridge is becoming disconnected from the iv line and leaking.It is happening only in preop.Product was used on a patient, there was no patient harm.

• Brand Name: CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6281234
• MDR Text Key: 65871975
• Report Number: 2050001-2017-00047
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 980202EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention