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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2020
Event Type  malfunction  
Event Description
It was reported that the filter/connector joint leaked.It did not lock onto the filter part (connection between catheter and filter).Per the anesthetist, it leaked as a result.The product was not being used on a patient when the product problem was observed.
 
Manufacturer Narrative
Additional information: d10, h6, h10.Device evaluation: one used decontaminated mp960 epidural flat filter was received without its original packaging for analysis.According to the investigation, visual inspection found rotating collar missing on returned filter and each flat filter contains retention edge which was designed to hold rotating collar connected with filter.The investigation reported that the retention edge on returned sample was found to be damaged and therefore could not hold rotating collar in place.According to the investigation, user issue and supplied item fault caused the reported issue.The problem source of the reported problem is user interface.
 
Manufacturer Narrative
Other, other text: device evaluation: one used decontaminated mp960 epidural flat filter was received without its original packaging for analysis.According to the investigation, visual inspection found rotating collar missing on returned filter and each flat filter contains retention edge which was designed to hold rotating collar connected with filter.The investigation reported that the retention edge on returned sample was found to be damaged and therefore could not hold rotating collar in place.According to the investigation, user issue and supplied item fault caused the reported issue.The problem source of the reported problem is user interface.
 
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Brand Name
PORTEX EPIDURAL CONTINUOUS TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10071567
MDR Text Key191453595
Report Number3012307300-2020-04572
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 user facility
Type of Report Initial,Followup,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number100/391/118CZ
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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