MAUDE Adverse Event Report: CAREFUSION; MAPLESON BAG

Model Number 2K8027

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/16/2013

Event Type  Injury  

Event Description

While using mapleson bag the green bag piece completely detached from the white plastic adapter.Large pressures were not being used.Operator initiated breaths on 90% fio2 used on servo vent while a new bag was obtained.

• Type of Device: MAPLESON BAG
• Manufacturer (Section D): CAREFUSION; vernon hills IL 60061
• MDR Report Key: 3628125
• MDR Text Key: 16593405
• Report Number: MW5034418
• Device Sequence Number: 1
• Product Code: KNE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2K8027
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO