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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. MEDEX STOPCOCK; STOPCOCK, I.V. SET
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SMITHS MEDICAL ASD; INC. MEDEX STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number MX934Y-1LCZ
Device Problem Gas/Air Leak (2946)
Patient Problems Nausea (1970); Tachycardia (2095); Increased Respiratory Rate (2486)
Event Date 10/09/2019
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical medex¿ stopcock had "torn air" and that it was leaking.The patient was reported to be receiving continuous renal replacement therapy (crrt) when they experienced nausea, shortness of breath (sob), and heart rate increase.The patient was then disconnected immediately and recovered.Treatment was restarted with a new medex stopcock with no further adverse effects.
 
Manufacturer Narrative
Three samples were received in original packaging.Visual inspection confirmed that product was produced according the drawing specification with no issue observed.Functional testing was performed to check flow/leakage; unable to confirm the reported customer complaint.
 
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Brand Name
MEDEX STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9527276
MDR Text Key173176745
Report Number3012307300-2019-07300
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2023
Device Catalogue NumberMX934Y-1LCZ
Device Lot Number3629678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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