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

Model Number 041210002A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Sample expected to return for evaluation.Follow-up report will be submitted once the sample has been received and reviewed.

Event Description

Argon 4-way stopcock was cracked, causing fluid to leak from iv hookup.No patient harm.Used:tubing /iv sets.

Manufacturer Narrative

A review of one stopcock assembly 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

Argon 4-way stopcock was cracked, causing fluid to leak from iv hookup.No patient harm.Used:tubing /iv sets.

• Brand Name: CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
• Type of Device: STOPCOCKS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11930369
• MDR Text Key: 261524430
• Report Number: 0001625425-2021-00951
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00886333201389
• UDI-Public: 00886333201389
• Combination Product (y/n): N
• PMA/PMN Number: K780271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1