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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
Model Number 450952-NL
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, the breathing filter got easily detached from the breathing circuit. No patient involvement.
 
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Brand NamePORTEX GENERAL ANESTHESIA CIRCUITS
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer (Section G)
NULL
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
2-12-12, kitanagase-omotemachi
minneapolis, MN 55442
MDR Report Key14102947
MDR Text Key289189133
Report Number3012307300-2022-06303
Device Sequence Number1
Product Code CAI
UDI-Device Identifier15019315075834
UDI-Public15019315075834
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K002506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number450952-NL
Device Catalogue Number450952-NL
Device Lot Number4112669
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2022
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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