MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. STOPCOCKS; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 041210002A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Argon medical device product clear 4 way stop cock leaked some times as reported by the nurse doing apheresis.

• Brand Name: STOPCOCKS
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road,; athens TX 75751
• MDR Report Key: 15904338
• MDR Text Key: 304693545
• Report Number: 15904338
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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: 11422515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1