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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA CONDUCTION KIT

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NULL PORTEX ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NCE6401JP
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: only the month ((b)(6)) and year (2021) of the event date are known. (b)(6).
 
Event Description
It was reported that medical fluid was leaking from the connector. This product problem was observed during use. This product problem did not cause or contribute to any adverse patient health effects.
 
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Brand NamePORTEX
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key12005460
MDR Text Key256482581
Report Number3012307300-2021-06082
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCE6401JP
Device Lot Number210118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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