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

Model Number	041210002A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Our 4 way stopcock was connected to the patient and then to the contrast line.3 occasion where the stopcock would continuously leak from the center port and 1 occasion where it sucked in air through the line.
Additional Manufacturer Narrative
According to the customer, the sample was not available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a root cause and corrective action is not possible.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.32 sealed samples were returned for review.There was no sample marked defective returned.Five random samples were leak tested using a water filled syringe and two out of the five leaked from underneath the core/handle.Therefore, this complaint was confirmed.A closer examination of the core/handle assembly confirmed the core/handle was not fully seated inside the stopcock body which would result in leakage.The most probable cause for the leakage was most likely related to the assembly of the core/handle with the stopcock body.The core/handle not being fully seated would result in the observed leakage.It could not be determined if the this issue was the result of a tolerance stack between the two components or if there was a machine malfunction that prevented the two components from seating properly.Engineering is aware of this issue and an investigation has been initiated to establish a definite root cause that will determine the corrective actions that need to be taken to prevent recurrence.
Event or Problem Description
Our 4 way stopcock was connected to the patient and then to the contrast line.3 occasion where the stopcock would continuously leak from the center port and 1 occasion where it sucked in air through the line.

• 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
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15486026
• Report Number: 0001625425-2022-01104
• Device Sequence Number: 17456966
• Product Code: FMG
• UDI-Device Identifier: 00886333201389
• UDI-Public: 00886333201389
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 041210002A
• Device Catalogue Number: 041210002A
• Device Lot Number: 11427759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown