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MAUDE Adverse Event Report: CAREFUSION; MAPLESON BAG
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CAREFUSION; MAPLESON BAG
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Model Number
2K8027
Device Problem
Detachment Of Device Component (1104)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date
12/20/2013
Event Type
Injury
Event Description
One liter mapleson bag came apart while bagging pt.White tap around green bag detached.Back-up was available and used.No harm to pt.
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Type of Device
MAPLESON BAG
Manufacturer
(Section D)
CAREFUSION
vernon hills IL 60061
MDR Report Key
3628126
MDR Text Key
15157168
Report Number
MW5034419
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
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
3 YR
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