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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT, ADULT
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SMITHS MEDICAL INTERNATIONAL LTD PORTEX ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT, ADULT Back to Search Results
Catalog Number 386000-NL
Device Problem Cut In Material (2454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2013
Event Type  malfunction  
Event Description
A report was receiving stating that during use of the listed device on a pt, the device's corrugated tubing was discovered to be torn and leaking.The circuit was disconnected and replaced.No adverse effects to pt reported.
 
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
ANESTHESIA BREATHING CIRCUIT, ADULT
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL LTD
hythe, kent
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3965958
MDR Text Key4611626
Report Number2183502-2014-00371
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number386000-NL
Device Lot Number13AB3689
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2014
Distributor Facility Aware Date10/17/2013
Event Location Hospital
Date Manufacturer Received10/17/2013
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
Type of Device Usage Unknown
Patient Sequence Number1
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