MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADULT COMFORT FLO NASAL CANNULA; CANNULA, NASAL, OXYGEN

Catalog Number 2411-01

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this complaint is still in progress at the time of this initial report.

Event Description

Customer complaint alleges "the cannula is kinking, causing back pressure in the circuit, and column, the pressure pop off, and the o2 tubing".No patient harm was reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).No device was returned for investigation.A device history record review could not be conducted as no lot number was provided.Customer complaint cannot be confirmed based on the information provided.Teleflex will continue to monitor feedback from customer for complaints of this nature.

Event Description

Customer complaint alleges "the cannula is kinking, causing back pressure in the circuit, and column, the pressure pop off, and the o2 tubing".No patient harm was reported.Patient condition reported as "fine".

• Brand Name: HUDSON ADULT COMFORT FLO NASAL CANNULA
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7847027
• MDR Text Key: 119333459
• Report Number: 3011137372-2018-00247
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2411-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1