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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT (SMJ OFTEN)
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NULL PORTEX ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT (SMJ OFTEN) Back to Search Results
Catalog Number 15248
Device Problem Unexpected Color (4055)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
A product sample was received for evaluation.Visual testing was performed.The manufacture and inspection records were reviewed and no related issues were found.The material of the ring collar was never changed all the time, each color scheme has a range requirement, the color of different batch products may be different, but they will be within the color range.The color was qualified.The actions that was taken was color limit samples were set up for the molding process for color controlling.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that before opening the package, the customer noticed the color of the current ring collar was "bluish" green while that of the previous one was completely green.No patient injury was reported.
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
ANESTHESIA BREATHING CIRCUIT (SMJ OFTEN)
Manufacturer (Section G)
NULL
MDR Report Key15416945
MDR Text Key306187372
Report Number3012307300-2022-19059
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
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 Catalogue Number15248
Device Lot Number191028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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