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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number 490804-NL
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during use of this device for a pediatric patient, the elbow piece of the circuits disconnected and had to be reattached. No patient injury was reported.
 
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Brand NamePORTEX ANESTHESIA BREATHING CIRCUIT
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)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14655713
MDR Text Key294656181
Report Number3012307300-2022-11558
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number490804-NL
Device Lot Number4264517
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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