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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET
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SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET Back to Search Results
Model Number MX9342L
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problems Underdose (2542); Blood Loss (2597); No Code Available (3191)
Event Date 09/07/2019
Event Type  malfunction  
Event Description
Patient's heart rate increased from 170's to 190's.Upon assessment, this nurse found that the (white) 4-way stopcock and the (yellow) 4-way stopcock on the patient's iv line had disconnected from each other, causing leaking of the patient's iv fluids & blood and delay in iv sedation/pain meds to the patient.Charge nurse alerted covering resident who came to bedside, while this rn stayed at bedside.Prn sedation given while waiting for continuous sedation to work.Repeat cbc ordered.
 
Event Description
Patient's heart rate increased from 170's to 190's.Upon assessment, this nurse found that the (white) 4-way stopcock and the (yellow) 4-way stopcock on the patient's iv line had disconnected from each other, causing leaking of the patient's iv fluids & blood and delay in iv sedation/pain meds to the patient.Charge nurse alerted covering resident who came to bedside, while this rn stayed at bedside.Prn sedation given while waiting for continuous sedation to work.Repeat cbc ordered.
 
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Brand Name
MEDEX
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9145811
MDR Text Key160895981
Report Number9145811
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMX9342L
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2019
Event Location Hospital
Date Report to Manufacturer10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age90 DA
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