MAUDE Adverse Event Report: CAREFUSION CARTRIDGE DISPOSABLE 3IN EXT SET STERILE; WARMER, THERMAL, INFUSION FLUID

Model Number 980202EU

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 12/01/2014

Event Type  Injury  

Event Description

(b)(4) - leak in medication infusion medication was leaking out of the cartridge.After inspection there was a burst in the cartridge between the hard material and the infusion line.  neither patient injury nor medical intervention has been reported.

Manufacturer Narrative

(b)(4) - the complaint cartridge was discarded and therefore not available for investigation.The lot number is unknown and no additional information is available.Because the device is unavailable, an evaluation could not be performed and root cause could not be determined.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: CARTRIDGE DISPOSABLE 3IN EXT SET STERILE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan, guangdong 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 4721236
• MDR Text Key: 5737288
• Report Number: 2242551-2015-00025
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 980202EU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention