MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. / CAREFUSION CAREFUSION STERILE WATER FOR INHALER 2 LITERS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number REF 2D0737

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/12/2019

Event Type  No Answer Provided  

Event Description

Sterile water for inhaler bag; on the overwrap there is a tiny sticker indicating it is not for parenteral administration.However, once the overwrap is opened, the port can be attached to iv infusion line and if the sterile water for inhalation is infused, it will result in death event.Just hoping fda will take action, so the sterile water for inhalation port does not allow the attachment of iv tubing to prevent the infusion of inhalation sterile water intravenously.Thank you.Fda safety report id# (b)(4).

• Brand Name: CAREFUSION STERILE WATER FOR INHALER 2 LITERS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC. / CAREFUSION
• MDR Report Key: 8692736
• MDR Text Key: 148004913
• Report Number: MW5087299
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: REF 2D0737
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1