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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL ACCESSORIES; CONNECTOR, AIRWAY (EXTENSION)
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NULL ACCESSORIES; CONNECTOR, AIRWAY (EXTENSION) Back to Search Results
Catalog Number 100/250/001
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2020
Event Type  malfunction  
Event Description
It was reported that the swivel was leaking air.No patient injury was reported.
 
Manufacturer Narrative
Other, udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (510k) number is unknown.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.No problem was found.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).
 
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Brand Name
ACCESSORIES
Type of Device
CONNECTOR, AIRWAY (EXTENSION)
Manufacturer (Section G)
NULL
MDR Report Key15417030
MDR Text Key300389382
Report Number3012307300-2022-19066
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date10/23/2023
Device Catalogue Number100/250/001
Device Lot Number3719550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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