MAUDE Adverse Event Report: WESTMED COMFORT SOFT PLUS NEONATAL CANNULA; NASAL CANNULA

Catalog Number	0167
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When removing the pt's ng tube and tape, the nasal cannula tubing was noted to be brittle.The tubing broke into two pieces, about 6 inches from the nasal prongs.

• Brand Name: COMFORT SOFT PLUS NEONATAL CANNULA
• Common Device Name: NASAL CANNULA
• Manufacturer (Section D): WESTMED; tucson AZ 8506
• MDR Report Key: 7872531
• Report Number: MW5079770
• Device Sequence Number: 174166
• Product Code: CAT
• UDI-Device Identifier: 00709078002748
• UDI-Public: (01)00709078002748
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0167
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 4