MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML; HUMIDIFICATION AND FILTERING

Model Number AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

No pictures and sample provided for evaluation.The customer stated that the product was discarded.Therefore, no root cause can be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the airlife¿ sterile water for inhalation, usp, 500 ml experienced missing hole that allows a connection to the o2 and the cannula.The therapist had to poke a hole in the top and nasal cannula connection to get it to work.The customer confirmed that patient o2 desaturated.But was caught in time to prevent further harm.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML
• Type of Device: HUMIDIFICATION AND FILTERING
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12052099
• MDR Text Key: 257849262
• Report Number: 3007502289-2021-00004
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403070983
• UDI-Public: (01)10885403070983(10)TL2008076
• Combination Product (y/n): N
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML
• Device Catalogue Number: 002620
• Device Lot Number: TL2008076
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention