MAUDE Adverse Event Report: QUEST MEDICAL 4-WAY HIGH FLOW STOPCOCK

Model Number	STV01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report received from nipro canada.Product code stv01.Device easily disconnected from an iv extension set.
Additional Manufacturer Narrative
All luer connections on the stopcock are iso80369-7 compliant and are tested for axial loading, unscrewing, and overriding per the iso standards.It is unknown if the luer connection for the needleless injection site the customer is using with the stopcock is also iso80369-7 compliant.At this time, the complaint could not be confirmed as manufacturing related.Complaint was confrimed, disconnection was noted.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK
• Common Device Name: HIGH FLOW STOPCOCK
• Manufacturer (Section D): QUEST MEDICAL; one allentown pkwy; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL; one allentown pkwy; allen TX 75002
• Manufacturer Contact: gail sauers ; one allentown pkwy; allen, TX 75002 ; 9842639140
• MDR Report Key: 16658589
• Report Number: 1649914-2023-00013
• Device Sequence Number: 19244787
• Product Code: FMG
• UDI-Device Identifier: 00634624911017
• UDI-Public: 00634624911017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: STV01
• Device Catalogue Number: 9652
• Device Lot Number: 63903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown