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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C45101340-NLJ
Device Problem Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
Only the month ((b)(6)) and year (2020) of the event date are known.(b)(6).
 
Event Description
It was reported that during a pre-use check, the customer noticed that air was leaking from the portex general anesthesia circuit.There was no patient involvement.
 
Manufacturer Narrative
Device evaluation: two used devices were returned for evaluation.Visual inspection was performed; no discrepancies were identified.The devices were given functional testing; this showed the devices passed with no leakage.The reported issue was not confirmed.
 
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Brand Name
PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key10948853
MDR Text Key219868083
Report Number3012307300-2020-12111
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/12/2023
Device Catalogue NumberC45101340-NLJ
Device Lot Number3986649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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