MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK

Model Number	041210002A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample expected to return for evaluation.
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
• Common Device Name: STOPCOCK
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11856206
• Report Number: 0001625425-2021-00925
• Device Sequence Number: 3551250
• Product Code: DTL
• UDI-Device Identifier: 00886333201389
• UDI-Public: 00886333201389
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K780271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: 041210002A
• Device Catalogue Number: 041210002A
• Device Lot Number: 11347865
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention