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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING C; CAG
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NULL PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING C; CAG Back to Search Results
Catalog Number C49201668D-NL
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the elbow and the y piece will not stay connected.Customer felt as if there was silicon in the y piece causing them to not slide into one another properly.
 
Manufacturer Narrative
Other, other text: one photo was used for investigation.Upon inspection, it was found that the complained issue could not be duplicated.No root cause can be determined since the complaint was not confirmed due samples, clear pictures of the failure were not received to perform an investigation.Dhr review was done, no issues related to the original complaint were found.
 
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Brand Name
PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING C
Type of Device
CAG
Manufacturer (Section G)
NULL
MDR Report Key12920262
MDR Text Key281660514
Report Number3012307300-2021-12166
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2022
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 Health Professional
Device Catalogue NumberC49201668D-NL
Device Lot Number4169741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2021
Initial Date FDA Received12/02/2021
Supplement Dates Manufacturer Received02/09/2022
Supplement Dates FDA Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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