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

Model Number	AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HUMIDIFICATION AND FILTERING
• MDR Report Key: 12052099
• Report Number: 3007502289-2021-00004
• Device Sequence Number: 19936356
• Product Code: BTT
• UDI-Device Identifier: 10885403070983
• UDI-Public: (01)10885403070983(10)TL2008076
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K853146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention