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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. HIGH-FLOW 4-WAY 45 PSI STOPCOCK, OFF HANDLE POSITION, ROTATING ADAPTER; STOPCOCK, I.V. SET
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MEDLINE INDUSTRIES, INC. HIGH-FLOW 4-WAY 45 PSI STOPCOCK, OFF HANDLE POSITION, ROTATING ADAPTER; STOPCOCK, I.V. SET Back to Search Results
Model Number DYNJSC401
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 03/20/2021
Event Type  malfunction  
Event Description
Patient needed blood cultures collected.I used two stop cocks to draw blood.When i went to flush after pulling the blood, and i couldn't.I disconnected and flushed directly on the line rather than through the stop cocks.The line flushed fine, but i noticed there was blood stuck in the new cap i had put on the patient's port line.I had to change the cap again because of this.The stop cocks i used are new alternative because of normal ones are out of stock.I believe it was the stop cocks that are possibly causing the blood in the cap.There was no detectable harm.The device involved was discarded.
 
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Brand Name
HIGH-FLOW 4-WAY 45 PSI STOPCOCK, OFF HANDLE POSITION, ROTATING ADAPTER
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl
mundelein IL 60060
MDR Report Key11626896
MDR Text Key244187651
Report Number11626896
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDYNJSC401
Device Catalogue NumberDYNJSC401
Device Lot Number21BBS677
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Event Location Hospital
Date Report to Manufacturer04/07/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age730 DA
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