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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
Model Number NCE6401JP
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.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.
 
Event Description
It was reported that immediately after starting to use the product, the customer noticed medical fluid was leaking from the epifuse connector.Also, he felt resistance through the connector when closing it.No patient injury.
 
Manufacturer Narrative
Other, other text: the epifuse connector was returned.Defective component (epifuse connector) item number : 30-4498-001, lot number : 322685-1.Results: as a result of observing the sample, a crack was found on the sleeve of the connector and there was no abnormality in the hinge part.In addition, a stock catheter was connected and water was injected with a syringe, but water flowed normally and no liquid leakage was observed.Conclusion: the reported event was not confirmed.Root cause: the root cause was not identified.Actions: we will notify manufacturing site of this event and record this event in a database to monitor future occurrences.
 
Event Description
Device evaluation completed.Summary in h 10.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11781542
MDR Text Key249226267
Report Number3012307300-2021-03893
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
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNCE6401JP
Device Catalogue NumberNCE6401JP
Device Lot Number210118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2021
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 Initial
Patient Sequence Number1
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