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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; BREATHING-CIRCUIT
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; BREATHING-CIRCUIT Back to Search Results
Model Number C37101368-NLJ
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
During a pre-use check, leakage of air from the smiths medical anesthesia circuit was detected.No patient injury.
 
Manufacturer Narrative
Investigation completed on a smiths medical breathing|portex general anesthesia circuits.Pictures were submitted and sample received p/n c37101368-nlj, l/n unknown.Upon visual inspection from 12 revealed a tear was observed in the circuit.Production reviewed and prior to release the product passed at 100%.Quality takes a sample using an aql 0.25 and level inspection gii per lot, in order to verify is free from damage, tubing is verify corrugations are not crushed or dented.Leak test is perform using aql 0.25 and level inspection gii per lot to ensure product does not leak.The leak believe to occur after leaving shm facility.
 
Event Description
Investigation completed and follow up report in h 10.
 
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Brand Name
PORTEX
Type of Device
BREATHING-CIRCUIT
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key11116515
MDR Text Key225056942
Report Number3012307300-2021-00056
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,foreig
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/14/2022
Device Model NumberC37101368-NLJ
Device Catalogue NumberC37101368-NLJ
Device Lot Number3864779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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