MAUDE Adverse Event Report: VEGA CHINA, VEGA TECHNOLOGICS CN 01 OR 02 PUMP

Device Problems Component or Accessory Incompatibility (2897); Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2016

Event Type  malfunction  

Event Description

A cheap (b)(6) nebulizer made by vega and then own branded by nebulizer manufacturers is being sold in the us, europe, global.The device had a qa engineer report condemning the fact that the unit is lubricated with a contaminated grease that comes in contact with the patient airway, and mixes with the patient drug when inhaling through their cheap (b)(6) compressor nebulizer (made by vega in (b)(6)).This report (details below was ignored by the respective company in the (b)(6)).Molykote 111 compound is not to be used with liquid oxygen and should not be used in applications requiring lox compatibility.Handling precautions: molykote 111 compound may cause temporary discomfort when in direct contact with eyes.In case of eye contact, flush eyes with water.Product safety information required for safe use is not included in this document.Before handling, read product and material safety data sheets and container labels for safe use, physical and health hazard information.The material safety data sheet is available on the dow corning web site at dowcorning.Com, or from your dow corning sales application engineer, or distributor, or by calling dow corning customer service packaging information.This product is available in different standard container sizes.Detailed container size information should be obtained from your nearest dow corning sales office or dow corning distributor.Limitations: this product is neither tested nor represented as suitable for medical or pharmaceutical uses.Limitations: this product is neither tested nor represented as suitable for medical or pharmaceutical uses.

• Brand Name: CN 01 OR 02 PUMP
• Type of Device: CN 01 OR 02 PUMP
• Manufacturer (Section D): VEGA CHINA, VEGA TECHNOLOGICS
• MDR Report Key: 6131542
• MDR Text Key: 61206067
• Report Number: MW5066371
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1