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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 4WAY STOPCOCK W/ MLL
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ARGON MEDICAL DEVICES 4WAY STOPCOCK W/ MLL Back to Search Results
Catalog Number 03-452004000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
One stopcock was returned for review.The stopcock was examined and no cracks or defects were observed.The core/handle was observed to be seated into the base properly.The stopcock was leak tested under water at 15 psi and leakage was confirmed where the core/handle fits into the base.The most probable cause for the leaking stopcock was most likely due to a error in the molding process of either the core/handle and/or the body of the stopcock that formed a gap when the two components were assembled that resulted in the leakage.Argon will continue to monitor for issues of this nature in the future.
 
Event Description
Stopcock leak identified between the stopcock handle and the base, when rotated to the flow position when tested at 15 psi.Leak rate is approximately 5 cc/min.
 
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Brand Name
4WAY STOPCOCK W/ MLL
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10285091
MDR Text Key199859382
Report Number1625425-2020-00407
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 other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03-452004000
Device Lot Number11299707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2020
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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