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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; ANESTHESIA CONDUCTION KIT
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PORTEX; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NCE6112JP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Customer/facility phone number: (b)(6).Company representative phone number: (b)(6).Device evaluation in progress.
 
Event Description
It was reported that during the use of the product, the customer noticed that medical fluid was leaking from the epifuse connector.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11169652
MDR Text Key226781360
Report Number3012307300-2021-00401
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 company representative,foreig
Type of Report Initial,Followup
Report Date 02/19/2021
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 No Information
Device Catalogue NumberNCE6112JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received01/14/2021
Supplement Dates Manufacturer Received01/19/2021
Supplement Dates FDA Received02/18/2021
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 N
Patient Sequence Number1
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