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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
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ARGON MEDICAL DEVICES CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK Back to Search Results
Model Number 041210002A
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
Sample expected to return for evaluation.
 
Event Description
6 argon clear 4-way stopcock needing to be changed out for different medex 4-way stopcock w/ swivel male luer lock due to leaking at connection sites.Units appear to be cracked causing backflow of blood into iv "tree".4 of the 6 are available for return.Used : tubing/iv sets.
 
Manufacturer Narrative
A review of four stopcock assemblies found severe damage/cracks to the luers which would result in leakage, confirming the complaint.Root cause investigation found no discrepancies with the molding process or the annealing process which could be factors in the failure observed.Additional testing was conducted on in-house parts, pre and post anneal process, and the damage/cracks could not be duplicated.The cause of the damage/cracks may possibly be related to the type of substance used to wipe the product or that was injected through the product.The ifu warns, ¿do not use patient monitoring products with parenteral nutritional solutions containing lipids or nitroglycerin.These substances are known to degrade some medical plastics resulting in cracks and/or leaks.Other drugs or solutions may have similar effects¿.The user facility has not responded to requests for additional information to confirm if incompatible substances were used on the product.
 
Event Description
6 argon clear 4-way stopcock needing to be changed out for different medex 4-way stopcock w/ swivel male luer lock due to leaking at connection sites.Units appear to be cracked causing backflow of blood into iv "tree".4 of the 6 are available for return.Used: tubing/iv sets.
 
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Brand Name
CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
Type of Device
STOPCOCK
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
MDR Report Key11856206
MDR Text Key261523589
Report Number0001625425-2021-00925
Device Sequence Number1
Product Code DTL
UDI-Device Identifier00886333201389
UDI-Public00886333201389
Combination Product (y/n)N
PMA/PMN Number
K780271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number041210002A
Device Catalogue Number041210002A
Device Lot Number11347865
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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