MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; CANNULA, NASAL, OXYGEN

Model Number IPN044066

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem Respiratory Distress (2045)

Event Date 01/24/2019

Event Type  malfunction  

Event Description

Nursing and respiratory therapy staff have reported multiple incidents of the nasal cannula kinking near the connection junction and impeding air flow, resulting in respiratory distress.This has been observed to occur with the baby's head movement, and not with repositioning the baby.

• Brand Name: HUDSON RCI
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8381467
• MDR Text Key: 137522958
• Report Number: 8381467
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IPN044066
• Device Catalogue Number: 2411-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 DA