MAUDE Adverse Event Report: CAREFUSION; MAPLESON BAG

Model Number 2K8027

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/01/2014

Event Type  Injury  

Event Description

While manually bagging pt during active desaturation episode, pt's mapleson bag fell apart where the green reservoir bag part is taped on to the white adapter piece.

• Type of Device: MAPLESON BAG
• Manufacturer (Section D): CAREFUSION; vernon hill IL 60061
• MDR Report Key: 3628119
• MDR Text Key: 4202877
• Report Number: MW5034414
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2K8027
• Device Lot Number: 0000619017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 MO