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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; ANESTHESIA CONDUCTION KIT
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; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 200428
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that during use the device leaked between connector and filter.No adverse effects to patient reported.
 
Manufacturer Narrative
Other, other text: device evaluation- one device was returned for evaluation.The flat filter and epidural connector were connected as per device instructions.Fluid was passed through the components with no leakage occurring.The reported issue was not confirmed during testing.
 
Manufacturer Narrative
Other, other text: device evaluation- one device was returned for evaluation.The flat filter and epidural connector were connected as per device instructions.Fluid was passed through the components with no leakage occurring.The reported issue was not confirmed during testing.
 
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Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10608569
MDR Text Key209235888
Report Number3012307300-2020-09996
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 11/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number200428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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