MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS; WARMER, THERMAL, INFUSION FLUID

Catalog Number 980202EU

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation results: an evaluation was performed on the returned sample cartridge which included a functional and leak test.The cartridge received was inspected and leak tested and met all requirements.The extension was then inspected and was found to have a male luer connector with deformed threads.The connector was from cavity 7, of the mold.This is consistent with previous complaints with similar problems.The device history record was reviewed for the lot number provided, and no issues were noted during manufacturing that may have caused this issue.The probable root cause is related to supplier- defective component.The root cause of this failure is tracked under (b)(4).

Event Description

Under investigation one more cartridge with leakage when connected to stopcock.Not able to screw luer properly.Users changed to a new cartridge and the problem was solved.Issue before the procedure.Neither patient injury nor medical intervention has been reported.

• Brand Name: CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 north riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan 53262 0; CH 532620
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd.; mettawa, IL 92887
• MDR Report Key: 7117872
• MDR Text Key: 94943033
• Report Number: 2050001-2017-00087
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• PMA/PMN Number: K121775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 980202EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1