MAUDE Adverse Event Report: QUEST MEDICAL INC HIGH-FLOW 4-WAY STOPCOCK EXTENSION; STOPCOCK, I.V. SET

Model Number HFST01

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Failure of the 4-way stopcock iv tubing extension.The failure occurred at the tubing-stopcock interface.Manufacturer response for 4-way stopcock with tubing extension, high-flow 4-way stopcock ext set (per site reporter), no response yet.

• Brand Name: HIGH-FLOW 4-WAY STOPCOCK EXTENSION
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): QUEST MEDICAL INC; 1 allentown pkwy; allen TX 75002
• MDR Report Key: 18255196
• MDR Text Key: 329572396
• Report Number: 18255196
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2023

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
• Device Operator: Health Professional
• Device Model Number: HFST01
• Device Catalogue Number: 910357 REV A
• Device Lot Number: 69536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1