MAUDE Adverse Event Report: CAREFUSION / VYAIRE MEDICAL, INC. CAREFUSION CIRCUIT AND BREATHING; CIRCUIT, BREATHING (W CONNECTOR, ADAPTER Y PIECE

Model Number A4UX2044

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Event Description

When preparing for operating room case, staff prepping room.Found a tear in the anesthesia carefusion tubing.Tubing removed from room, and new tubing set up.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: CAREFUSION CIRCUIT AND BREATHING
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTER Y PIECE
• Manufacturer (Section D): CAREFUSION / VYAIRE MEDICAL, INC. ; yorba linda CA 10341
• MDR Report Key: 8785263
• MDR Text Key: 151028262
• Report Number: MW5088045
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A4UX2044
• Device Lot Number: 0004094921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 84