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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, EXPANDABLE BREATHING SYSTEMS
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, EXPANDABLE BREATHING SYSTEMS Back to Search Results
Catalog Number C45101340-NLJ
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
 
Event Description
It was reported that before opening the package, the customer found a red pen line at three (3) places on the outer box.No patient injury or adverse affects.The customer provided the photo of the box.No additional information is available for this complaint at this time.
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
CIRCUIT, EXPANDABLE BREATHING SYSTEMS
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
2-12-12, kitanagase-omotemachi
minneapolis, MN 55442
MDR Report Key14986734
MDR Text Key295700293
Report Number3012307300-2022-13258
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 Other
Type of Report Initial
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC45101340-NLJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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